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16SOFT-Neo-7-50

by Salter Labs, LLC

Part of a family of 61 devices: see the family page

Ref 16SOFT-NEO-7-50Model Salter Oxygen Cannulas

16SOFT-Neo-7-50 is a device classified as Class IIa in the EU and Class I in the US made by Salter Labs, LLC, registered in EUDAMED on 11 May 2026 (Basic UDI-DI 0607411TF20017a_O2CannLL) and listed in FDA GUDID since 9 Feb 2018 (UDI-DI 10607411952620), 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 Number0607411TF20017a_O2CannLL Basic UDI-DI 10607411952620UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10607411952620 UDI-DI Date9 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0607411TF20017a_O2CannLL registered 11 May 2026 Active
  • FDA GUDID UDI-DI 10607411952620 listed 9 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10607411952620
  2. Registered EUDAMED 0607411TF20017a_O2CannLL

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  • Withdrawn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
Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube
Generic name
Nasal oxygen cannula, basic
Model / Ref / Catalog
16SOFT-NEO-7-50, Salter Oxygen Cannulas, 16SOFT-NEO-7
Primary DI / UDI-DI
10607411952620
Basic UDI-DI
0607411TF20017a_O2CannLL
Unit of use DI
00607411952623
FDA product code
CAT
EMDN code
R0301020301 Oxygen therapy standard nasal cannulas (goggles)
GMDN term
Nasal oxygen cannula, basic
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5340
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Nasal oxygen cannula, basic

Similar devices in this category

Other devices filed under OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES).

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Contains endocrine-disrupting substances
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)