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Statlock VCDC2

by Bard Access Systems, Inc.

Ref VCDC2

Statlock VCDC2 is a wearable percutaneous catheter/tube holder (EU MDR Class I; FDA Class I; FDA product code KMK, Device, Intravascular Catheter Securement) made by Bard Access Systems, Inc., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 0801741MCUFFNGVUE) and listed in FDA GUDID since 9 Nov 2023 (UDI-DI 00801741083082), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741MCUFFNGVUE Basic UDI-DI 00801741083082UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741083082 UDI-DI Date9 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0801741MCUFFNGVUE registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 00801741083082 listed 9 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00801741083082
  2. Registered EUDAMED 0801741MCUFFNGVUE

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  • Withdrawn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
Statlock
Generic name
Wearable percutaneous catheter/tube holder, single-use
Device name
BD StatLock™ Stabilization Device - PICC Sterile
Model / Ref / Catalog
VCDC2
Primary DI / UDI-DI
00801741083082
Basic UDI-DI
0801741MCUFFNGVUE
FDA product code
KMK
EMDN code
V0599 Clinical procedures kits not included in other classes - other
GMDN term
Wearable percutaneous catheter/tube holder, single-use
Device class
Class I
Regulation number
880.5210
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
StatLock™ stabilization device procedure pack is intended for securing compatible medical tubes or catheters.
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wearable percutaneous catheter/tube holder

Similar devices in this category

Other devices filed under CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Bard Access Systems, Inc.

See all devices from Bard Access Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)