← Back to catalogue

Game Ready

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
Game Ready FDA UDI
Generic Name
Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
Device Name
Elbow Sleeve FDA UDI
Model / Reference
510200-03 FDA UDI
Description
Elbow Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
00812120001764 FDA UDI
FDA Product Code
IRP FDA UDI
ILO 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 UDI
890.5720 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal/compression therapy system wrap

Game Ready 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI 64b350b1-4f31-42d0-a0bf-9c1455be361e 33 fields · synced Jun 9, 2026