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Cold Rush

FDA UDI

Class II (US FDA UDI)

by Ossur Americas

Identity

Trade Name
Cold Rush FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system control unit FDA UDI
Device Name
Kit Cold Rush w/Shlder Pad LG FDA UDI
Model / Reference
B-232000016 FDA UDI
Description
Kit Cold Rush w/Shlder Pad LG FDA UDI

Identifiers

Catalog Number
B-232000016 FDA UDI
Primary DI / UDI-DI
05690977342484 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system control unitCirculating-fluid localized thermal therapy system pack, single-use

Cold Rush by Ossur Americas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ossur Americas

Sources (1)

  • FDA UDI a6206b6a-5858-4bf9-aa63-096e848c13e5 35 fields · synced Jun 6, 2026