Disposable Respiratory Products, Neo-Pod T

GUDID 00709078006005

Universal Neonatal Transport Circuit with Lavabed

WESTMED, INC.

Heated respiratory humidifier
Primary Device ID00709078006005
NIH Device Record Key449532d2-0e20-4e1b-afb0-6eef4b483e9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Respiratory Products, Neo-Pod T
Version Model Number9402U
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
GS100709078006005 [Primary]
GS110709078006002 [Package]
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 Date2018-10-26
Device Publish Date2018-09-25

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