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Monoject 400BE

by Cardinal Health 200, LLC

Ref 400BEModel Enteral Feeding Syringes and Accessories

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000000786R Basic UDI-DI 20192253007159UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20192253007159 UDI-DI Date12 Oct 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Monoject
Generic Name
ENFit oral/enteral syringe, single-use
Device Name
Enteral Feeding Syringes and Accessories
Model / Ref / Catalog
400BE, Enteral Feeding Syringes and Accessories
Primary DI / UDI-DI
20192253007159
Basic UDI-DI
063014000000000000000786R
Unit of Use DI
10192253007152
FDA Product Code
PNR
EMDN Code
A0280 Syringes - accessories
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5980
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: ENFit oral/enteral syringe, single-use

Other devices from Cardinal Health 200, LLC

See all devices from Cardinal Health 200, LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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
  • Manufacturing Date: No