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Comfit Cuff Preformed Large 9-17 H-CL22CAN

by Omron Healthcare, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00073796223144 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Comfit Cuff Preformed Large 9"-17"
Generic Name
Blood pressure cuff, reusable
Model / Ref / Catalog
H-CL22CAN
Primary DI / UDI-DI
00073796223144
510(k) Number
FDA Product Code
DXN
GMDN Term
Blood pressure cuff, reusable
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure cuff, reusable

Cleared under the same submission (K042506)

Other devices from Omron Healthcare, Inc.

See all devices from Omron Healthcare, Inc. →

Properties

  • Over-the-Counter
  • Lot / Batch Number

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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No