NomoLine-O™ LH Infant/Neonatal Airway Adapter Set

GUDID 17350046132518

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 ID: 17350046132518
• NIH Device Record Key: a735e3e1-3ab9-42e0-9fc5-b82f41bc57db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NomoLine-O™ LH Infant/Neonatal Airway Adapter Set
• Version Model Number: 4640
• Company DUNS: 632369067
• Company Name: Masimo Sweden AB
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350046132511 [Unit of Use]
GS1	17350046132518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171121

FDA Product Code

• BYH: Drain, Tee (Water Trap)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-07
• Device Publish Date: 2019-10-30

Devices Manufactured by Masimo Sweden AB

• 07350046132139 - ISA™ Gas Exhaust Kit: 2021-09-22
• 07350046132658 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula: 2021-01-26
• 07350046132665 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula: 2021-01-26
• 07350046132672 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula with O2: 2021-01-26
• 07350046132689 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula with O2: 2021-01-26
• 07350046132290 - ISA™ CO2: 2021-01-18
• 07350046131996 - Radius PCG™: 2020-10-27
• 07350046132009 - Radius PCG™: 2020-10-27