SENSIMEDICAL Sterile Water for Inhalation, USP 7871800000

GUDID 00810083350264

Sterile Water for Inhalation, USP, 1000 mL

Sensimedical LLC

Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier

Primary Device ID	00810083350264
NIH Device Record Key	dbd501f8-51a0-4cd1-8a97-107c09786355
Commercial Distribution Status	In Commercial Distribution
Brand Name	SENSIMEDICAL Sterile Water for Inhalation, USP
Version Model Number	7871800000
Catalog Number	7871800000
Company DUNS	117526048
Company Name	Sensimedical LLC
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	00810083350264 [Package] Contains: 00810083350271 Package: [14 Units] In Commercial Distribution
GS1	00810083350271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K881184

FDA Product Code

BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-07-01
Device Publish Date	2022-06-23

On-Brand Devices [SENSIMEDICAL Sterile Water for Inhalation, USP]

00810083350295	Sterile Water for Inhalation, USP, 2000 mL
00810083350264	Sterile Water for Inhalation, USP, 1000 mL