FL9000

GUDID 05055931111009

Respiratory Humidifier Single Use Temperature Probe

FLEXICARE MEDICAL LIMITED

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

Primary Device ID	05055931111009
NIH Device Record Key	753e27de-6b77-473b-bd0b-b3741d2b6ec8
Commercial Distribution Status	In Commercial Distribution
Brand Name	FL9000
Version Model Number	FL9000-04U
Company DUNS	504406273
Company Name	FLEXICARE MEDICAL LIMITED
Device Count	1
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	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055931111009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161314

FDA Product Code

BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

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	2024-03-22
Device Publish Date	2024-03-14

On-Brand Devices [FL9000]

05055931112983	Respiratory Humidifier Single Use Temperature Probe (Sterile)
05055931111009	Respiratory Humidifier Single Use Temperature Probe