No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812311029140 | G8-3035-SH-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Large, Right | ||
2 | 00812311029089 | GS-3035-SH-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 4-Chamber Arm & Shoulder Sleeve - Large, Right | ||
3 | 00812311022172 | GS-3045-S-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small | ||
4 | 00812311022042 | IC-1545-DLI | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-DLI | ||
5 | 00812311021908 | GS-3045-L/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Large Black | ||
6 | 00812311021861 | GC-3045-XL/B | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Leg Extra Large - Black | ||
7 | 00812311021724 | G8-3045-S-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Small | ||
8 | 00812311021618 | GC-3045-KC | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems BioCryo Knee | ||
9 | 00812311021601 | GC-3045-A | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems BioCryo Ankle | ||
10 | 00812311021564 | SC-3004-DL | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-3004-DL | ||
11 | 00812311021281 | SC-3004 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-3004 | ||
12 | 00812311021151 | IC-1545-F | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-F | ||
13 | 00812311020888 | GS-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small | ||
14 | 00812311020819 | GS-3035-SH/L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Arm and Shoulder Sleeve Large | ||
15 | 00812311020741 | GN-3045-S/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small Narrow - Black | ||
16 | 00812311020406 | GBA-3045-L-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Bio Abdominal Left Leg - Large | ||
17 | 00812311020390 | GA-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Leg - Small | ||
18 | 00812311020321 | G8-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Small | ||
19 | 00812311020291 | G8-3035-SH/S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm & Shoulder Sleeve - Small | ||
20 | 00812311020284 | G8-3035-SH/M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm & Shoulder Sleeve - Medium | ||
21 | 00812311020123 | CG-3035-C | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Custom 4 Chamber Arm Sleeve | ||
22 | 00812311020086 | BCC-100 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Carrying Case Blue | ||
23 | 00812311020024 | A8-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Medium Adjustable | ||
24 | 00812311023667 | CI-3035-B | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Cryo Insert Back | ||
25 | 00812311023063 | GID-1000-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | VascuEase Replacement Sleeve, Right | ||
26 | 00812311022080 | SC-2004-NZ | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-NZ | ||
27 | 00812311021885 | GID-3045-T | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems DVT Calf/Thigh Sleeve Digital Pair | ||
28 | 00812311021762 | GC-3035-EC/B | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Elbow Cylinder - Black | ||
29 | 00812311021700 | G8-3045-L-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Large | ||
30 | 00812311021540 | SC-2004-OC | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-OC | ||
31 | 00812311021441 | GV-3010-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Elite 8 Bio Vest Large Right | ||
32 | 00812311021229 | SC-2004-230 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-230 | ||
33 | 00812311021182 | IC-1545-PSP | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-PSP | ||
34 | 00812311021175 | IC-1545-P | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-P | ||
35 | 00812311021083 | GWA8-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Adjustable Wide Leg Medium | ||
36 | 00812311020727 | GN-3045-M/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow - Black | ||
37 | 00812311020628 | GC-3045-L | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Leg Large | ||
38 | 00812311020543 | GC1-3045-A | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Multi-FLO DVT Combo Cyro Ankle Sleeve | ||
39 | 00812311020383 | GA-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Leg - Medium | ||
40 | 00812311020338 | GA-3035-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Arm - Large | ||
41 | 00812311020307 | G8-3045-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Large | ||
42 | 00812311020260 | G8-3035-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm Sleeve - Small | ||
43 | 00812311020239 | CP-S | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Bio Cryo Gel Insert - Small | ||
44 | 00812311020048 | APG-3035-FA | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Arterial Full Arm Sleeve | ||
45 | 00812311022011 | IC-1200-WH | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | VascuEase | ||
46 | 00812311029119 | G8-3035-SH-M-L | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Medium, Left | |
47 | 00812311029096 | G8-3035-SH-S-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Small, Left | ||
48 | 00812311029027 | SC-3008-DL-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | BioTAB Sequential Circulator | ||
49 | 00812311029010 | SC-2004-OC-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | BioTAB Sequential Circulator | ||
50 | 00812311027610 | CI-3035-E | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Cryo Insert Elbow |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10885632112720 | HTPW24 | Pad Heat Therapy Large Polyurethane 18 X 24 Inch Reusable Not Made With Natural Pad Heat Therapy Large Polyurethane 18 X 24 Inch Reusable Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
2 | 10885632112713 | HTPW20 | Pad Heat Therapy Medium Polyurethane 14 X 20 Inch Reusable Not Made With Natural Pad Heat Therapy Medium Polyurethane 14 X 20 Inch Reusable Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
3 | 10885632112706 | HTPW17 | Pad Heat Therapy Small Polyurethane 12 X 17 Inch Reusable Not Made With Natural Pad Heat Therapy Small Polyurethane 12 X 17 Inch Reusable Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
4 | 10885632112690 | HTP500 | Pump Heat Therapy Mercury-Free Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
5 | 10885632112683 | HTP024 | Pad Heat Therapy Large Polyurethane 18 X 24 Inch Single Patient Use Not Made Wit Pad Heat Therapy Large Polyurethane 18 X 24 Inch Single Patient Use Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
6 | 10885632112676 | HTP020 | Pad Heat Therapy Medium Polyurethane 14 X 20 Inch Single Patient Use Not Made Wi Pad Heat Therapy Medium Polyurethane 14 X 20 Inch Single Patient Use Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
7 | 10885632112669 | HTP017 | Pad Heat Therapy Small Polyurethane 12 X 17 Inch Single Patient Use Not Made Wit Pad Heat Therapy Small Polyurethane 12 X 17 Inch Single Patient Use Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
8 | 10885632112652 | HTP003 | Pad Heat Therapy Neck Polyurethane 4 X 19 Inch Single Patient Use Not Made With Pad Heat Therapy Neck Polyurethane 4 X 19 Inch Single Patient Use Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
9 | 10885632112645 | HTBW60 | Blanket Therapeutic Hypo Hyperthermia Adult Polyurethane 24 X 60 Inch Reusable N Blanket Therapeutic Hypo Hyperthermia Adult Polyurethane 24 X 60 Inch Reusable Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
10 | 10885632112638 | HTBW30 | Blanket Therapeutic Hypo Hyperthermia Pediatric Polyurethane 24 X 30 Inch Reusab Blanket Therapeutic Hypo Hyperthermia Pediatric Polyurethane 24 X 30 Inch Reusable Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
11 | 10885632112621 | HTB060 | Blanket Therapeutic Hypo Hyperthermia Adult Polyurethane 24 X 60 Inch Not Made W Blanket Therapeutic Hypo Hyperthermia Adult Polyurethane 24 X 60 Inch Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
12 | 10885632112614 | HTB030 | Blanket Therapeutic Hypo Hyperthermia Pediatric Polyurethane 24 X 30 Inch Not Ma Blanket Therapeutic Hypo Hyperthermia Pediatric Polyurethane 24 X 30 Inch Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
13 | 10850007350083 | 8002-062-026 | Temperature Therapy Pad | Mul-T-Pad | C2DX, INC. | |
14 | 10850007350076 | 8002-062-012 | Temperature Therapy Pad | Mul-T-Pad | C2DX, INC. | |
15 | 10660584000178 | DTSP1 | Dynatron Solaris Plus ThermoStim Probe | DYNATRONICS CORPORATION | ||
16 | 10615089620208 | ST-H2 | 6202-0001 | Accessory Hose Set for Baxter/Gaymar/Stryker Units | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
17 | 10615089620109 | ST-H1 | 6201-0001 | Accessory Hose Set for CSZ Unit | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
18 | 10615089311601 | TFR-1 | 3116-0001 | Water Temp / Flow Rate Tester; HTP1500 Pump | HTP1500 Accessory | ADROIT MEDICAL SYSTEMS, INC. |
19 | 10615089311106 | HTPS1500 | 3111-0001 | Accessory Rolling Stand for HTP1500 Pump | HTP1500 | ADROIT MEDICAL SYSTEMS, INC. |
20 | 10615089310901 | Bed Bracket | 3109-0001 | Bed Bracket for HTP1500 Pump | Accessory; HTP1500 Bed Bracket | ADROIT MEDICAL SYSTEMS, INC. |
21 | 10615089310505 | MI-12 | 3105-0001 | Portable Motorized Cold Therapy Unit | Mobile Ice | ADROIT MEDICAL SYSTEMS, INC. |
22 | 10615089310307 | IVPB-HTP1500 | 3103-0001 | IV Pole Bracket for HTP1500 | Accessory; HTP1500 | ADROIT MEDICAL SYSTEMS, INC. |
23 | 10615089310208 | A3 | 3102-0001 | Surface Warming & Cooling System | Surface Warming & Cooling System | ADROIT MEDICAL SYSTEMS, INC. |
24 | 10615089310109 | HTP1500 | HTP1500 | Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free | HTP1500 | ADROIT MEDICAL SYSTEMS, INC. |
25 | 10615089126007 | ST-260 | ST-260 | Blanket Adult 24x60in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Wei Blanket Adult 24x60in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
26 | 10615089123006 | ST-230 | ST-230 | Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
27 | 10615089122405 | ST-224 | ST-224 | Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both S Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
28 | 10615089122009 | ST-220 | ST-220 | Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
29 | 10615089121705 | ST-217 | ST-217 | Pad Heat Small 12x17in (Filled Dimensions) Non-Woven Medium Weight Fabric Both S Pad Heat Small 12x17in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC Free Disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
30 | 10615089121200 | ST-212 | ST-212 | Pad for Motorized Cold Therapy Unit Shoulder Non-Sterile 12x12in w/straps. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
31 | 10615089116008 | WD-060 | WD-060 | Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/ Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
32 | 10615089113007 | WD-030 | WD-030 | Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer La Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free Disposable | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
33 | 10615089112406 | WD-024 | WD-024 | Pad Heat Large 18x24in (Filled Dimensions) All Polymer Latex/PVC Free Disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
34 | 10615089112000 | WD-020 | WD-020 | Pad Heat Medium 14x20 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
35 | 10615089111706 | WD-017 | WD-017 | Pad Heat Small 12x17 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
36 | 10615089109109 | CA-1 | 1091-0001 | Accessory Thermometer for Temp Probe Adapter Cable Esophageal Rectal Probe | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
37 | 10615089107006 | ST-900 | ST-900 | Cool Kit w/Head Wrap, Patient Vest and Blanket Wrap for Legs | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
38 | 10615089106009 | ST-060 | ST-060 | Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Both Sides; Latex/PVC Free; Disposable. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
39 | 10615089105002 | ST-050 | ST-050 | Head Wrap | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
40 | 10615089104401 | ST-044 | ST-044 | Patient Vest, Poncho Style, Elastic Straps | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
41 | 10615089104302 | ST-043 | ST-043 | Leg Pad, 12 x 14.5 in. , Elastic Mesh | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
42 | 10615089104104 | ST-041 | ST-041 | Arm Pad 8.5 x 9.5 in. Elastic Mesh. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
43 | 10615089104005 | ST-040 | ST-040 | Hyper-Hypothermia Patient Vest. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
44 | 10615089103107 | ST-031 | ST-031 | Leg Wrap | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
45 | 10615089103008 | ST-030 | ST-030 | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. | |
46 | 10615089102605 | ST-026 | ST-026 | Leg Pad, Insulated, Velcro Fasteners. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
47 | 10615089102407 | ST-024 | ST-024 | Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/ Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
48 | 10615089102100 | ST-021 | ST-021 | Wrist Pad, Insulated, Velcro Fasteners | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |
49 | 10615089102001 | ST-020 | ST-020 | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. | |
50 | 10615089101905 | ST-019 | ST-019 | Ankle Pad, Insulated, Velcro Fasteners. | Soft-Temp | ADROIT MEDICAL SYSTEMS, INC. |