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MEDRAD® Avanta Fluid Management Injection System

by Bayer Medical Care Inc. 12 variants

Ref AVA 500 BTLH-M

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0060I3B Basic UDI-DI Date5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258027203 UDI-DI Date6 May 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2296-2026 FDA Class II initiated 24 Apr 2026

    Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

    • Terminated Z-0870-2013 FDA Class II initiated 5 Nov 2012

    The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.

    • Terminated Z-2866-2011 FDA Unclassified (pre-2012) initiated 2 Jun 2011

    Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo

    • Terminated Z-1199-2010 FDA Unclassified (pre-2012) initiated 6 Jan 2010

    The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.

  • 2 recalls, same reason

    • Terminated Z-0083-06 FDA Unclassified (pre-2012) initiated 20 Sep 2005 on shared 510(k) K050456
    • Terminated Z-0082-06 FDA Unclassified (pre-2012) initiated 20 Sep 2005 on shared 510(k) K050456

    stress crack on the stopcock

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
MEDRAD® Avanta Fluid Management Injection System EUDAMED
MEDRAD® Avanta Heat Maintainer, Bottle - Medium GUDID
Generic Name
Angiography contrast medium injection system, line-powered, mobile
Model / Ref / Catalog
AVA 500 BTLH-M EUDAMED
AVA 500 BTLH-L GUDID
Primary DI / UDI-DI
00616258027203, 00616258022109
Basic UDI-DI
0616258TFCN-0060I3B
510(k) Number
FDA Product Code
DXT
EMDN Code
A030105 Fluids heating systems
GMDN Term
Angiography contrast medium injection system, line-powered, mobile
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AVA 500 BTLH-M
GUDID
AVA 500 BTLH-L
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No