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Powerloc

by Bard Access Systems, Inc. 4 variants

Ref 8671910

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 linked in EUDAMED

A group certificate may exist

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 Number0801741JOBXOCKQXS Basic UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741048371 UDI-DIDate12 Jan 2026ListedStatusListed 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.

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  • Withdrawn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

Generic Name
Vascular port administration set
Device Name
PowerLoc™ Safety Infusion Set
Model / Ref / Catalog
8671910
Primary DI / UDI-DI
00801741048371
Basic UDI-DI
0801741JOBXOCKQXS
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
Market of Registration
Poland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 1 Inch
Needle Gauge — 19 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017720
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

Other devices from Bard Access Systems, Inc.

See all devices from Bard Access Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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