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N/A 1003-0-50

by Salter Labs, LLC

Ref 1003-0-50Model Salter Nebulizers

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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 Number0607411TF20013d_NebEE Basic UDI-DI 10607411001014UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10607411001014 UDI-DI Date16 Dec 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.

Recalls

1 recall · FDA

    • Terminated Z-0108-2012 FDA Unclassified (pre-2012) initiated 25 Mar 2011

    A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.

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  • Withdrawn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
Mouth Piece, Standard 22mm
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
1003-0-50, Salter Nebulizers
Primary DI / UDI-DI
10607411001014 EUDAMED
00607411001017 GUDID
Basic UDI-DI
0607411TF20013d_NebEE
Unit of Use DI
00607411001017
FDA Product Code
CCQ
EMDN Code
R060101 Cold nebulisation systems
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
868.5640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10607411001014
GUDID
00607411001017
Device ClassEUDAMED
Class IIb
GUDID
Class I

Related devices

Category: Therapeutic agent nebulizer, benchtop

Cleared under the same submission (K870027)

Show all (12)

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No