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MEDRAD® Veris™ 8600 Vital Signs Monitor 3011541

by Bayer Medical Care Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 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 Number00616258009537 UDI-DI Date23 Jun 2017ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-0810-2014 FDA Class II initiated 21 Nov 2013

    The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.

    • Terminated Z-1586-2013 FDA Class II initiated 15 Apr 2013

    The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.

    • Terminated Z-0259-2007 FDA Unclassified (pre-2012) initiated 29 Sep 2006

    Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MEDRAD® Veris™ 8600 Vital Signs Monitor
Generic Name
Blood pressure cuff, single-use
Model / Ref / Catalog
3011541
Description
"Pediatric Blood Pressure Disposable Cuffs 7-10 in (17-25 cm) (BP CUFF,DISP,17-25CM,VERIS BX QTY 10,MC) (85278231)"
Primary DI / UDI-DI
00616258009537
510(k) Number
FDA Product Code
MWI
GMDN Term
Blood pressure cuff, single-use
Device Class
Class II
Regulation Number
870.2300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure cuff, single-use

Cleared under the same submission (K042569)

Show all (12)

Other devices from Bayer Medical Care Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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