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NomoLine™ LH Adult Nasal CO2 Cannula with O2 3820

by Masimo Corporation

Ref 3820

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 Number084399700000Z3T5D04V004ME Basic UDI-DI 17350046131252UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17350046131252 UDI-DI Date22 Dec 2017ListedStatusListed 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  • Withdrawn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
NomoLine LH Adult Nasal CO2 Cannula with O2, EUDAMED
NomoLine™ LH Adult Nasal CO2 Cannula with O2 GUDID
Generic Name
Gas-sampling/monitoring respiratory tubing, single-use
Device Name
NomoLine Nasal Cannula with O2
Model / Reference
3820
Primary DI / UDI-DI
17350046131252
Basic UDI-DI
084399700000Z3T5D04V004ME
Unit of Use DI
07350046131255
FDA Product Code
CCK
EMDN Code
R020108 Respiratory gas monitoring and sampling circuits and kits
GMDN Term
Gas-sampling/monitoring respiratory tubing, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.1400
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 II

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No