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Adult Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer style connection.

by Salter Labs, LLC

Ref 5012-1-25, 1600-1-50, 1600-16-50Model Salter Sleep Diagnostic Cannulas, Salter Oxygen Cannulas

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0607411TF20010_SleepDx9V Basic UDI-DI Date6 May 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Adult Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer style connection.
Nasal Cannula (Adult) Salter Style, 1’ (0.3 m) supply tube
Model / Reference
Salter Sleep Diagnostic Cannulas, 5012-1-25, Salter Oxygen Cannulas, 1600-1-50, 1600-16-50
Primary DI / UDI-DI
10607411500265, 10607411100007, 10607411100076
Basic UDI-DI
0607411TF20010_SleepDx9V, 0607411TF20017a_O2CannLL
Unit of Use DI
00607411500268, 00607411100000, 00607411100079
EMDN Code
Z12100585, R0301020301
Device Class
Class I
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000007934
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

From the manufacturer

Manufacturer's product page: Ballard™ Turbo-Cleaning Closed Suction Systems with QWIKCLIP

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Properties

Other properties (13)

  • Sterile: 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