Arctic Flex RHB2084BLKXXL

by Vive Health LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850041211480 UDI-DI	Date27 Jul 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Arctic Flex
Generic Name: Musculoskeletal hot/cold therapy pack, reusable
Model / Reference: RHB2084BLKXXL

Primary DI / UDI-DI: 00850041211480
FDA Product Code: IME
GMDN Term: Musculoskeletal hot/cold therapy pack, reusable

Device Class: Class I
Regulation Number: 890.5700
GUDID distribution status: In Commercial Distribution

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Properties

Over-the-Counter
Premarket Exempt

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No