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Broselow BP3535

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number10885403300738 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2277-2019 FDA Class II initiated 3 Jun 2019

    Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Broselow
Generic Name
Blood pressure cuff, single-use
Model / Ref / Catalog
BP3535
Primary DI / UDI-DI
10885403300738
510(k) Number
FDA Product Code
DXQ
GMDN Term
Blood pressure cuff, single-use
Device Class
Class II
Regulation Number
870.1120
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K080854)

Show all (12)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No