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Remel R064622

by Remel, Inc.

Remel R064622 is a Class I device made by Remel, Inc., cleared under FDA 510(k) K965152 on 22 Jan 1997 and listed in FDA GUDID since 22 Dec 2022 (UDI-DI 00848838009860), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K965152

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848838009860 UDI-DI Date22 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK965152 Date22 Jan 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K965152 decided 22 Jan 1997 Active
  • FDA GUDID UDI-DI 00848838009860 listed 22 Dec 2022 Listed

Recalls

1 recall · FDA

    • Terminated Z-1139-2010 FDA Unclassified (pre-2012) initiated 18 Jan 2010

    Pouch may be inadequately heat sealed compromising sterility

Timeline

3 dated events

  1. Cleared FDA 510(k) K965152
  2. Recall initiated FDA recalls Z-1139-2010
  3. Listed FDA GUDID 00848838009860

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Remel
Generic name
Microbiological transport medium IVD
Model / Ref / Catalog
R064622
Primary DI / UDI-DI
00848838009860
510(k) Number
FDA product code
JSM
GMDN term
Microbiological transport medium IVD
Device class
Class I
Regulation number
866.2390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microbiological transport medium IVD

Cleared under the same submission (K965152)

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)