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Diagnostix™ 728-609-11AR

by American Diagnostic Corporation

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 23 Oct 2026. What this means

Overview

For individuals with cardiovascular health, the Diagnostix Blood Pressure Cuff is a convenient and accurate way to monitor blood pressure. The device features an inflatable cuff that fits around the limb, an inflation bulb for controlling air pressure within the cuff, an aneroid manometer, and tubing. This results in reliable blood pressure measurement in conjunction with a stethoscope.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00634782066345 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Diagnostix™
Generic Name
Aneroid manual sphygmomanometer
Model / Ref / Catalog
728-609-11AR
Primary DI / UDI-DI
00634782066345
FDA Product Code
DXQ
GMDN Term
Aneroid manual sphygmomanometer
Device Class
Class II
Regulation Number
870.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Aneroid manual sphygmomanometer

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No