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Cardinal Health

by Jiangsu Caina Medical Co., Ltd. 12 variants

Ref 8881112015Model 12mL

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-26971564466848 Basic UDI-DI 26971564466848UDI-DIDate19 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number26971564466848 UDI-DI Date8 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0850-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0848-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0847-2024 FDA Class I initiated 28 Dec 2023
    • Ongoing Z-0849-2024 FDA Class I initiated 28 Dec 2023

    The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
ENFit oral/enteral syringe, single-use
Device Name
Enteral Feeding and Irrigation Syringes
Model / Ref / Catalog
12mL, 8881112015
Primary DI / UDI-DI
26971564466848
Basic UDI-DI
B-26971564466848
510(k) Number
FDA Product Code
PNR
EMDN Code
A020108 Enteral feeding syringes
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011217
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Caina Medical Co., Ltd.

See all devices from Jiangsu Caina Medical Co., Ltd. →

Properties

  • Single Use
  • Administering Medicine
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No