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Port Access Needle 0631915

by Bard Access Systems, Inc.

Part of a family of 33 devices: see the family page

Ref 0631915

Port Access Needle 0631915 is a device classified as Class IIa in the EU and Class II in the US made by Bard Access Systems, Inc., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 0801741NPERWKIL4F) and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 00801741047510), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741NPERWKIL4F Basic UDI-DI 00801741047510UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741047510 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0801741NPERWKIL4F registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 00801741047510 listed 22 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00801741047510
  2. Registered EUDAMED 0801741NPERWKIL4F

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  • Withdrawn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
Miniloc EUDAMED
Port Access Needle GUDID
Generic name
Vascular port administration set
Device name
MiniLoc™ Safety Infusion Set
Model / Ref / Catalog
0631915
Primary DI / UDI-DI
00801741047510
Basic UDI-DI
0801741NPERWKIL4F
FDA product code
FPA
EMDN code
A03040199 Infusion kits (with or w/o pump), single-use - other
GMDN term
Vascular port administration set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 19 Gauge
Length — 1.5 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular port administration set

Similar devices in this category

Other devices filed under INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER.

Other devices from Bard Access Systems, Inc.

See all devices from Bard Access Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)