NomoLine-O™ LH Adult Nasal/Oral CO2 Cannula with O2 4m

GUDID 17350046132495

Masimo Sweden AB

Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use
Primary Device ID17350046132495
NIH Device Record Key406f6e72-e791-4e66-ae77-05b1952b2dcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNomoLine-O™ LH Adult Nasal/Oral CO2 Cannula with O2 4m
Version Model Number4638
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
GS107350046132498 [Unit of Use]
GS117350046132495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYHDrain, Tee (Water Trap)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-04
Device Publish Date2020-01-27

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.