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StatLock Pro PGNS002

by Bard Access Systems, Inc.

Ref PGNS002

StatLock Pro PGNS002 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 28 Oct 2026 (Basic UDI-DI 0801741HJICJVMDQT) and listed in FDA GUDID since 25 Jan 2019 (UDI-DI 10801741163729), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741HJICJVMDQT Basic UDI-DI 10801741163729UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801741163729 UDI-DI Date25 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0801741HJICJVMDQT registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 10801741163729 listed 25 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10801741163729
  2. Registered EUDAMED 0801741HJICJVMDQT

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  • Withdrawn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 EUDAMED
StatLock Pro GUDID
Generic name
Wearable percutaneous catheter/tube holder, single-use
Device name
StatLock™ IV Pad(BNS)
Model / Ref / Catalog
PGNS002
Primary DI / UDI-DI
10801741163729
Basic UDI-DI
0801741HJICJVMDQT
Unit of use DI
00801741163722
FDA product code
KMK
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Wearable percutaneous catheter/tube holder, single-use
Device class
Class I
Regulation number
880.5210
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10801741163729: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Wearable percutaneous catheter/tube holder

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Bard Access Systems, Inc.

See all devices from Bard Access Systems, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)