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 | 00862103000307 | NICE1 | Cold + Compression Therapy Unit | NICE | NICE RECOVERY SYSTEMS LLC | |
2 | 00862103000307 | NICE1 | Cold + Compression Therapy Unit | NICE | NICE RECOVERY SYSTEMS LLC | |
3 | 00861047000312 | CRYOPress | massager, powered inflatable tube | CRYOPress | GRIMM SCIENTIFIC INDUSTRIES INC | |
4 | 00854682001950 | 003-47 | 003-47 | ThermaZone Range of Motion (ROM) Knee Brace with Advanced Heating / Cooling Therapy | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
5 | 00854682001943 | 003-30 | 003-30 | ThermaZone Single Patient Use Shoulder Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
6 | 00854682001929 | 003-73 | 003-73 | ThermaZone Medical Grade Power Supply Assembly. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
7 | 00854682001615 | 003-08 | 003-08 | ThermaZone Thermal Therapy Device with medical grade power supply. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
8 | 00854682001578 | 003-07 | 003-07 | ThermaZone Thermal Therapy Device with standard power supply | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
9 | 00854682001561 | 003-35 | 003-35 | ThermaZone Standard Power Supply Assembly. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
10 | 00854682001547 | 003-79 | 003-79 | ThermaZone Hospital Bed Bracket. This device can attach directly to the patient' ThermaZone Hospital Bed Bracket. This device can attach directly to the patient's bed or to the ThermaZone IV pole with base. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
11 | 00854682001523 | 003-26 | 003-26 | ThermaZone Single Patient Use Hip Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
12 | 00854682001509 | 003-29 | 003-29 | ThermaZone Single Patient Use Ankle Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
13 | 00854682001493 | 003-28 | 003-28 | ThermaZone Single Patient Use Back Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
14 | 00854682001486 | 003-27 | 003-27 | ThermaZone Single Patient Use Knee Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
15 | 00854682001356 | 003-99 | 003-99 | ThermaZone Thermal Therapy Device with medical grade power supply | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
16 | 00854682001349 | 003-22 | 003-22 | ThermaZone Universal Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
17 | 00854682001301 | 003-11 | 003-11 | ThermaZone Occipital Rear Head Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
18 | 00854682001172 | 003-04 | 003-04 | ThermaZone Blue Tubing Assembly | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
19 | 00854682001158 | 003-19 | 003-19 | ThermaZone Ankle Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
20 | 00854682001141 | 003-18 | 003-18 | ThermaZone Back Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
21 | 00854682001134 | 003-17 | 003-17 | ThermaZone Knee Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
22 | 00854682001127 | 003-20 | 003-20 | ThermaZone Large Shoulder Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
23 | 00854682001110 | 003-15 | 003-15 | ThermaZone Shoulder Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
24 | 00854682001042 | 003-10 | 003-10 | ThermaZone Front & Side Head Relief Pad | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
25 | 00854682001028 | 003-12 | 003-12 | ThermaZone Eye Relief Pad. | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC |
26 | 00850998008980 | ManaCold | MANACOLD01 | ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and m ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad.Commonly used following knee surgery, shoulder surgery or back surgeryManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting | ManaMed | MANAMED INC |
27 | 00850998008294 | FLIGHT001 | The PlasmaFlight is a portable and rechargeable device. It is intended to be an The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. | PlasmaFlight | MANAMED INC | |
28 | 00850023727077 | RP-ALM071H | RENPHO Leg Massager | JOICOM CORPORATION | ||
29 | 00850023727053 | RF-ALM070 | RENPHO Leg Massager | JOICOM CORPORATION | ||
30 | 00850023727046 | RP-ALM070H | RENPHO Leg Massager | JOICOM CORPORATION | ||
31 | 00850023727039 | RF-ALM071 | RENPHO Leg Massager | JOICOM CORPORATION | ||
32 | 00850007350147 | TP700C | T/pump Professional | T/Pump | C2DX, INC. | |
33 | 00850007350130 | TP700 | T/pump Professional | T/Pump | C2DX, INC. | |
34 | 00850001185073 | KLV20005 | Kelvi Hand Station | Kelvi | HYPOTHERMIA DEVICES, INC. | |
35 | 00850001185059 | KLV20004 | Kelvi Ankle Pro Smart Wrap | Kelvi | HYPOTHERMIA DEVICES, INC. | |
36 | 00850001185042 | KLV20003 | Kelvi Knee Pro Smart Wrap | Kelvi | HYPOTHERMIA DEVICES, INC. | |
37 | 00850001185035 | KLV20002 | Kelvi Back Pro Smart Wrap | Kelvi | HYPOTHERMIA DEVICES, INC. | |
38 | 00850001185028 | KLV20001 | Kelvi Shoulder Pro Smart Wrap | Kelvi | HYPOTHERMIA DEVICES, INC. | |
39 | 00850001185011 | KLV40001 | Kelvi Pro Umbilical | Kelvi | HYPOTHERMIA DEVICES, INC. | |
40 | 00850001185004 | KLV10001 | Kelvi Pro Console | Kelvi | HYPOTHERMIA DEVICES, INC. | |
41 | 00850001096270 | Therm-X Extender Straps | TX0109 | Therm-X Extender Straps | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
42 | 00850001096270 | Therm-X Extender Straps | TX0109 | Therm-X Extender Straps | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
43 | 00850001096256 | Therm-X Disposable Calf DVT Garment | TX0107 | Therm-X Disposable Calf DVT Garment | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
44 | 00850001096256 | Therm-X Disposable Calf DVT Garment | TX0107 | Therm-X Disposable Calf DVT Garment | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
45 | 00850001096232 | Therm-X Back SPU | TX0305 | Therm-X Back SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
46 | 00850001096232 | Therm-X Back SPU | TX0305 | Therm-X Back SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
47 | 00850001096225 | Therm-X Hip SPU | TX0308 | Therm-X Hip SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
48 | 00850001096225 | Therm-X Hip SPU | TX0308 | Therm-X Hip SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
49 | 00850001096218 | Therm-X Ankle SPU | TX0304 | Therm-X Ankle SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |
50 | 00850001096218 | Therm-X Ankle SPU | TX0304 | Therm-X Ankle SPU | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC |