Neo-Pod T Circuit

GUDID 10709078008181

60" Neonatal Transport Circuit w/LavaBed, Exhalation Valve

WESTMED, INC.

Heated respiratory humidifier
Primary Device ID10709078008181
NIH Device Record Key1221c9a8-41c5-4b2f-aae5-4d5b82f457e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo-Pod T Circuit
Version Model Number9399
Company DUNS092673953
Company NameWESTMED, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078008184 [Primary]
GS110709078008181 [Package]
Contains: 00709078008184
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-08
Device Publish Date2019-10-31

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