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AirLife 1005-0

by Salter Labs, LLC

Ref 1005-0-25Model Skin Fixation Devices

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 Number0607411TF20011_SkinFixAR Basic UDI-DI 10607411001021UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10607411001021 UDI-DI Date30 Nov 2016ListedStatusListed 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  • Withdrawn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

Trade Name
Tender Grip, Cannula fixation device EUDAMED
AirLife GUDID
Generic Name
Skin-cover adhesive strip, non-antimicrobial
Model / Ref / Catalog
Skin Fixation Devices, 1005-0-25, 1005-0
Primary DI / UDI-DI
10607411001021 EUDAMED
00607411001024 GUDID
Basic UDI-DI
0607411TF20011_SkinFixAR
Unit of Use DI
00607411001024
FDA Product Code
KGX
EMDN Code
R03010280 Oxygen therapy masks and nasal cannulas - accessories
GMDN Term
Skin-cover adhesive strip, non-antimicrobial
Device Class
Class I
Regulation Number
880.5240
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Skin Fixation Devices
1005-0-25
GUDID
1005-0
Primary DI / UDI-DIEUDAMED
10607411001021
GUDID
00607411001024

Related devices

Category: Skin-cover adhesive strip, non-antimicrobial

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No