| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00606959048331 | 2.21 | 1099731 | Software, EncorePro2, web | BZD,MNS,MNT | VENTILATOR, NON-CONTINUOUS (RESPIRATOR),VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORT VENTILATOR, NON-CONTINUOUS (RESPIRATOR),VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING,VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | 2 | EncorePro |
| 2 | 00606959054165 | Disposable Proximal Pressure Line, 84 in | 312121 | MNT | Ventilator, continuous, minimal ventilatory support, facility use | 2 | BiPAP | |
| 3 | 00606959023772 | 00 | 1116682 | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear | |
| 4 | 00606959023383 | 00 | 1116717 | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear | |
| 5 | 00606959060838 | 00 | 1146458 | M, DreamWear Dm Plw, Med Frm WO HGR,GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 6 | 00606959060821 | 00 | 1146457 | S, DreamWear Dm Plw, Med Frm WO HGR,GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 7 | 00606959060784 | 00 | 1146453 | S, DreamWear Dm Plw, Sm Frm WO HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 8 | 00606959060760 | 00 | 1146451 | MW, DreamWear Dm Plw, Lg Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 9 | 00606959060753 | 00 | 1146450 | L, DreamWear Dm Plw, Lg Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 10 | 00606959060746 | 00 | 1146449 | M, DreamWear Dm Plw, Lg Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 11 | 00606959060739 | 00 | 1146448 | S, DreamWear Dm Plw, Lg Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 12 | 00606959060722 | 00 | 1146417 | MW, DreamWear Dm Plw, Med Frm WHGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 13 | 00606959060715 | 00 | 1146416 | L, DreamWear Dm Plw, Med Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 14 | 00606959060708 | 00 | 1146415 | M, DreamWear Dm Plw, Med Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 15 | 00606959060685 | 00 | 1146413 | MW, DreamWear Dm Plw, Sm Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 16 | 00606959060678 | 00 | 1146412 | L, DreamWear Dm Plw, Sm Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 17 | 00606959060661 | 00 | 1146411 | M, DreamWear Dm Plw, Sm Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 18 | 00606959060654 | 00 | 1146410 | S, DreamWear DM Plw, SM Frm W HGR, GBL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 19 | 00606959060401 | JAPAN | 1047990X | Alice PDx Portable Sleep Diagnostic System, Japan | MNR | Ventilatory effort recorder | 2 | Alice PDX Assembly, JP |
| 20 | 00606959059665 | 00 | 1125023KR | Large DreamWear Gel Pillow Large Frame with Headgear Korea | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 21 | 00606959059658 | 00 | 1125016KR | Medium DreamWear Gel Pillows Medium Frame with Headgear Korea | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | Dreamwear |
| 22 | 00606959059641 | 00 | 1125018KR | Small DreamWear Gel Pillows Small Frame with Headgear Korea | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | Dreamwear |
| 23 | 00606959059634 | 00 | 1116692KR | Large DreamWear Under the Nose Large Frame with Headgear Korea | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 24 | 00606959059627 | 00 | 1116685KR | Small DreamWear Under the Nose Small Frame with Headgear Korea | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 25 | 00606959058361 | 00 | 1136631UA | DreamWear Gel Pillows, Starter Pack, Ukraine | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 26 | 00606959058354 | 00 | 1116696UA | DreamWear Under the Nose Nasal, FitPack, Ukraine | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 27 | 00606959057845 | System One Heated Tube Humidifier, FR | FR6T | System One Heated Humidifier, International | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | SYSTEM ONE |
| 28 | 00606959057838 | System One Heated Humidifier, FR | FR6H | System One Heated Humidifier, France | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | SYSTEM ONE |
| 29 | 00606959057777 | 00 | 1144025 | SmallMedium DreamWear Gel Pillows Kit withHeadgear, Global | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 30 | 00606959050594 | 1137431 | 1137431 | DreamWear Full Lab Mask, Extended Sizepack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 31 | 00606959050587 | 1137430 | 1137430 | DreamWear Full Lab Mask, Medium Frame, Fitpack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 32 | 00606959050570 | 1137409 | 1137409 | DreamWear Pillow Lab Mask, Medium, Medium Frame, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 33 | 00606959050563 | 1137408 | 1137408 | DreamWear Pillow Lab Mask, Small, Small Frame, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 34 | 00606959050556 | 1137407 | 1137407 | DreamWear Plw Lab Mask, Small, Medium Frame, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 35 | 00606959050549 | 1137410 | 1137410 | DreamWear Pillow Lab Mask, Combopack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 36 | 00606959050525 | 1137400 | 1137400 | DreamWear Pillow Lab Mask, Med Frame, Fitpack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 37 | 00606959050303 | 1137389 | 1137389 | DreamWear Nasal Lab Mask, Medium, Medium Frame, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 38 | 00606959050297 | 1137388 | 1137388 | DreamWear Nasal Lab Mask, Small, Small Frame, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 39 | 00606959050280 | 1137390 | 1137390 | DreamWear Nasal Lab Mask, Small-Medium Combopack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 40 | 00606959050273 | 1137387 | 1137387 | DreamWear Nasal Lab Mask, Small, Med Frame, USA DOM | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 41 | 00606959050266 | 1137381 | 1137381 | DreamWear Nasal Lab Mask, Extended Sizepack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 42 | 00606959050259 | 1137380 | 1137380 | DreamWear Nasal Lab Mask, Medium Frame, Fitpack, USA | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 43 | 00606959049963 | 2.11 | 1136968 | DreamMapper iOS China Instance v 2.11 | MNS,BZD,MNT | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING,VENTILATOR, NON-CONTINUOUS (RESPIRAT VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING,VENTILATOR, NON-CONTINUOUS (RESPIRATOR),Ventilator, continuous, minimal ventilatory support, facility use | 2 | DreamMapper iOS China Instance v 2.11 |
| 44 | 00606959049888 | 2.11 | 1136946 | DreamMapper Web China Instance v 2.11 | MNT,MNS,BZD | Ventilator, continuous, minimal ventilatory support, facility use,VENTILATOR, CO Ventilator, continuous, minimal ventilatory support, facility use,VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING,VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamMapper Web China Instance v 2.11 |
| 45 | 00606959049871 | 2.11 | 1127937 | DreamMapper Web APAC Instance v 2.11 | BZD,MNT,MNS | VENTILATOR, NON-CONTINUOUS (RESPIRATOR),Ventilator, continuous, minimal ventilat VENTILATOR, NON-CONTINUOUS (RESPIRATOR),Ventilator, continuous, minimal ventilatory support, facility use,VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | 2 | DreamMapper Web (APAC) |
| 46 | 00606959049833 | System One Heated Tube Humidifier, CN | CNSYS1HT15 | System One Heated Tube Humidifier, China | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | System One Humidifier |
| 47 | 00606959049765 | DreamWear Gel Pillows Mask, Starter Pack, INTL | 1136631 | DreamWear Gel Pillows Mask, Starter Pack, INTL | BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 2 | DreamWear |
| 48 | 00606959048355 | Detachable Battery Module, USA and International | 1096770 | Detachable Battery Module, USA and International | MNT | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | 2 | Battery |
| 49 | 00606959048324 | Detachable Battery Pack,USA/International | 1043570 | Detachable Battery Pack, USA / International | MNT,CBK,MNS | Ventilator, continuous, minimal ventilatory support, facility use,VENTILATOR, CO Ventilator, continuous, minimal ventilatory support, facility use,VENTILATOR, CONTINUOUS, FACILITY USE,VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | 2 | Battery |
| 50 | 00606959048317 | SimplyGo Mini with 2 Standard Batteries, US | 1134722 | SimplyGo Mini with 2 Standard Batteries, US | CAW | Generator, oxygen, portable | 2 | SimplyGo Mini |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00815962020634 | BITS-3355 | Bioness Integrated Therapy System Version 3.0 Motion Sensor | BITS Motion Sensor | BIONESS INC. | |
| 2 | 00815962020627 | BITS-3155 | BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | BIONESS INC. | |
| 3 | 00815962020610 | BITS-3055 | Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS S Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | BIONESS INC. | |
| 4 | 00815962020245 | 2.0.5 | Bioness Integrated Therapy Software | Bioness Integrated System (BITS)2.0.5 | BIONESS INC. | |
| 5 | 00815962020238 | BIT-2048 | Bioness Integrated Therapy System, Version 2.0, 48" Display with Software | Bioness Integrated System (BITS)2.0.5 | BIONESS INC. | |
| 6 | 00815962020221 | BIT-2055 | Bioness Integrated Therapy System, Version 2.0, 55" Display with Software | Bioness Integrated System (BITS)2.0.5 | BIONESS INC. | |
| 7 | 00815962020214 | BIT-2224 | Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Displa Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software | Bioness Integrated System (BITS) Mobile Configuration | BIONESS INC. | |
| 8 | 00815962020122 | BIT-2124 | Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Displ Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software | Bioness Integrated System (BITS) Bedside Configuration | BIONESS INC. | |
| 9 | 00815962020054 | 2.0.1 | Bioness Integrated System (BITS)2.0.5 | BIONESS INC. | ||
| 10 | 00718175004401 | 852-000 | 852-000 | System 4 MVP | System 4 MVP | BIODEX MEDICAL SYSTEMS, INC. |
| 11 | 00718175004203 | 840-000 | 840-000 | System 4 Quick Set | System 4 Quick Set | BIODEX MEDICAL SYSTEMS, INC. |
| 12 | 00718175004067 | 850-822 | 850-822 | Biodex Multi-Joint-System 3 Rev.1 UpGrade | MJS System 3 Upgrade | BIODEX MEDICAL SYSTEMS, INC. |
| 13 | 00718175004050 | 850-820 | 850-820 | BIODEX SYSTEM 3 REMANUFACTURE | MJS System 3 Upgrade | BIODEX MEDICAL SYSTEMS, INC. |
| 14 | 00718175004005 | 850-000 | 850-000 | Biodex System 4 Pro | System 4 Pro | BIODEX MEDICAL SYSTEMS, INC. |
| 15 | 00606959057753 | Actiware, Software CD, US Gov. - 6 | 1143911 | Actiware, Software CD, US Gov. | Actiware | RESPIRONICS, INC. |
| 16 | 00606959042049 | Actiwatch Spectrum Plus, Japan | JP1101894 | Actiwatch Spectrum Plus Japan | Actiwatch Spectrum Plus | RESPIRONICS, INC. |
| 17 | 00606959042032 | Actiwatch Spectrum PRO Japan | JP1099351 | Actiwatch Spectrum PRO Japan | Actiwatch Spectrum Pro | RESPIRONICS, INC. |
| 18 | 00606959040366 | Actiware Clinical Trial Software, English - 6 | 1103609 | Actiware Clinical Trial Software, English | Actiware | RESPIRONICS, INC. |
| 19 | 00606959039872 | Actiware Software Web Download - 6 | 1104776 | Actiware Activity Analysis Software (for use with Actiwatch Activity Trackers) | Acitware | RESPIRONICS, INC. |
| 20 | 00606959021457 | Actiware Software CD - 6 | 1104775 | Actiware Software CD | Actiware | RESPIRONICS, INC. |
| 21 | 00606959021440 | Actiwatch Spectrum Plus | 1101894 | Actiwatch Spectrum Plus | Actiwatch | RESPIRONICS, INC. |
| 22 | 00606959021402 | Actiwatch Spectrum Pro | 1099351 | Actiwatch Spectrum Pro | Actiwatch | RESPIRONICS, INC. |
| 23 | 00606959021013 | 3.11 | 1081738 | Actical Software Global | Actical Software | RESPIRONICS, INC. |
| 24 | 00190446293613 | 13-4024 | MOTION INTELLIGENCE APP | RAW MATERIAL | DJO, LLC | |
| 25 | 00190446286974 | 11-4001-0-06000 | X4 KNEE BRACE, LT, UNIV, BLK | DONJOY | DJO, LLC | |
| 26 | 00190446286967 | 11-4000-0-06000 | X4 KNEE BRACE, RT, UNIV, BLK | DONJOY | DJO, LLC | |
| 27 | B534HUBER360MDUS1 | HUBER | HUBER | L P G SYSTEMS | ||
| 28 | 17540176010002 | RV10 | The ReJoyce is a rehabilitation device intended to increase the strength of musc The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities.The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games.The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life. | ReJoyce | REHABTRONICS INC | |
| 29 | 10850390007816 | LE1 | A recumbent, closed-chain exercise device that provides eccentric (negative) res A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface. | Eccentron | BTE TECHNOLOGIES, INC. | |
| 30 | 10850390007427 | MCU 2 | A rehabilitation device for neck strengthening exercises, as well as measurement A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes. | MCU Multi-Cervical Unit | BTE TECHNOLOGIES, INC. | |
| 31 | 10850390007380 | Prism1 | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | Prism | BTE TECHNOLOGIES, INC. | |
| 32 | 10850390007373 | Evaluator EV | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model. | Evaluator | BTE TECHNOLOGIES, INC. | |
| 33 | 10850390007366 | Evaluator EVJ | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. | EVJ | BTE TECHNOLOGIES, INC. | |
| 34 | 10850390007359 | 1 | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | Provider Test Kit (PTK) | BTE TECHNOLOGIES, INC. | |
| 35 | 10850390007342 | EV2 | Evaluator EV2 | BTE TECHNOLOGIES, INC. | ||
| 36 | 10850390007335 | Evaluator | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. | Evaluator | BTE TECHNOLOGIES, INC. | |
| 37 | 10850390007328 | EvalTech | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | EvalTech | BTE TECHNOLOGIES, INC. | |
| 38 | 10850390007311 | ER | ER | BTE TECHNOLOGIES, INC. | ||
| 39 | 09120077180076 | R1 | The LEXO is a mechatronic therapy system for body weight-supported gait rehabili The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk. | LEXO | TYROMOTION GMBH | |
| 40 | 08800043810121 | MW-V100 | Morning Walk | CUREXO, INC. | ||
| 41 | 08800043810022 | MW-S200 | AC-00000-000 | MW-S200 | Morning Walk | CUREXO, INC. |
| 42 | 08054701850022 | huno s | APC0000404 | huno s is a robotic medical device for functional sensorimotor rehabilitation an huno s is a robotic medical device for functional sensorimotor rehabilitation and evaluation of the lower limbs and trunk | huno s | MOVENDO TECHNOLOGY SRL |
| 43 | 08054701850015 | huno | APC0000403 | huno is a robotic medical device for functional sensorimotor rehabilitation and huno is a robotic medical device for functional sensorimotor rehabilitation and evaluation of the lower limbs and trunk | huno | MOVENDO TECHNOLOGY SRL |
| 44 | 08054701850008 | hunova | APC0000400 | hunova is a robotic medical device for functional sensorimotor rehabilitation an hunova is a robotic medical device for functional sensorimotor rehabilitation and evaluation of the lower limbs and trunk | hunova | MOVENDO TECHNOLOGY SRL |
| 45 | 08054329990001 | ICONE | Robotic system for neurorehabilitation and rehabilitation of the upper limbs and Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities. | Heaxel | HEALTH PIXEL SRL | |
| 46 | 07640174660254 | Pro | 32001 | Lokomat | HOCOMA AG | |
| 47 | 07640174660247 | Pro | 32000 | Lokomat | HOCOMA AG | |
| 48 | 07640174660223 | Nanos V1.2 | 31002 | Lokomat | HOCOMA AG | |
| 49 | 07640174660216 | Nanos V1.2 | 31001 | Lokomat | HOCOMA AG | |
| 50 | 07640174660209 | Nanos V1.2 | 31000 | Lokomat | HOCOMA AG |