Transport Kit with Adult Elongated Oxygen Mast

GUDID 10709078004787

WESTMED, INC.

Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing Oxygen administration tubing
Primary Device ID10709078004787
NIH Device Record Key9600dae2-8883-4f02-b547-a15dae77083a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransport Kit with Adult Elongated Oxygen Mast
Version Model Number9439
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 Kittrue
Device Combination Productfalse
Single Usefalse
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
GS100709078004780 [Primary]
GS110709078004787 [Package]
Contains: 00709078004780
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
OGLOxygen Administration Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-24
Device Publish Date2018-05-16

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