NomoLine™ LH Adult/Pediatric Airway Adapter Set

GUDID 17350046131191

Masimo Sweden AB

Gas-sampling/monitoring respiratory tubing, single-use, non-sterile
Primary Device ID17350046131191
NIH Device Record Key5262fdcc-c2f4-4050-97fc-b42fd93cf1e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNomoLine™ LH Adult/Pediatric Airway Adapter Set
Version Model Number3814
Company DUNS632369067
Company NameMasimo Sweden AB
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350046131194 [Unit of Use]
GS117350046131191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-22

Devices Manufactured by Masimo Sweden AB

07350046132139 - ISA™ Gas Exhaust Kit2021-09-22
07350046132658 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula2021-01-26
07350046132665 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula2021-01-26
07350046132672 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula with O22021-01-26
07350046132689 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula with O22021-01-26
07350046132290 - ISA™ CO22021-01-18
07350046131996 - Radius PCG™2020-10-27
07350046132009 - Radius PCG™2020-10-27

Trademark Results [NomoLine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOMOLINE
NOMOLINE
86185529 5418472 Live/Registered
Masimo Corporation
2014-02-05

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