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Self-Taking Blood Pressure Kit -Standard Adult Size Cuff 0104

by Omron Healthcare, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00073796010409 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Self-Taking Blood Pressure Kit -Standard Adult Size Cuff
Generic Name
Aneroid manual sphygmomanometer
Model / Reference
0104
Primary DI / UDI-DI
00073796010409
510(k) Number
FDA Product Code
DXQ
GMDN Term
Aneroid manual sphygmomanometer
Device Class
Class II
Regulation Number
870.1120
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K780715)

Other devices from Omron Healthcare, Inc.

See all devices from Omron Healthcare, Inc. →

Properties

  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: 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