SENSIMEDICAL Sterile Water for Inhalation, USP 7871800000

GUDID 00810083350264

Sterile Water for Inhalation, USP, 1000 mL

Sensimedical LLC

Non-heated respiratory humidifier
Primary Device ID00810083350264
NIH Device Record Keydbd501f8-51a0-4cd1-8a97-107c09786355
Commercial Distribution StatusIn Commercial Distribution
Brand NameSENSIMEDICAL Sterile Water for Inhalation, USP
Version Model Number7871800000
Catalog Number7871800000
Company DUNS117526048
Company NameSensimedical LLC
Device Count1
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810083350264 [Package]
Contains: 00810083350271
Package: [14 Units]
In Commercial Distribution
GS100810083350271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-01
Device Publish Date2022-06-23

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

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

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