Identity
- Trade Name
- Game Ready Med4 Elite Drain Hose FDA UDI
- Generic Name
- Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
- Device Name
- Drain Hose Kit MED4 Elite (Qty 2) FDA UDI
- Model / Reference
- 573240 FDA UDI
- Description
- Drain Hose Kit MED4 Elite (Qty 2) FDA UDI
Identifiers
- Catalog Number
- 573240 FDA UDI
- Primary DI / UDI-DI
- 00812120002662 FDA UDI
- 510(k) Number
- K171685 FDA UDI
- FDA Product Code
- IRP FDA UDIILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 FDA UDI890.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Circulating-fluid localized thermal/compression therapy system wrap
Game Ready Med4 Elite Drain Hose by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Circulating-fluid localized thermal/compression therapy system wrap.
- Aquilo Sports — AQUILO SPORTS L.L.C. · Class II
- VascuTherm5 — Thermotek, Inc. · Class II
- Aquilo Sports — AQUILO SPORTS L.L.C. · Class II
- PT9 — Thermotek, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready — Avanos Medical, Inc. · Class II
- Game Ready Left Shoulder Heat Exchanger, Rental — Avanos Medical, Inc. · Class II
Cleared under the same submission
K171685 also covers:
- GAME READY* MED4 Elite* Control Unit — Avanos Medical, Inc.
- GAME READY* MED4 Elite* System — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
- GAME READY* Med4 Elite* Accessory Kit — Avanos Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI a2ce08fa-119a-46f1-9ca1-fedfe8951430 36 fields · synced Jun 9, 2026