Anesthesia Breathing System

GUDID 10709078004312

Disposable Anesthesia Breathing System, 1/2L Latex Free Bag, Bleed Tail Valve

WESTMED, INC.

Breathing circuit bag, single-use
Primary Device ID10709078004312
NIH Device Record Key554b068f-d7aa-4a6b-a4b2-30990b073cc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnesthesia Breathing System
Version Model Number9584
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100709078004315 [Primary]
GS110709078004312 [Package]
Contains: 00709078004315
Package: [30 Units]
In Commercial Distribution

FDA Product Code

BTCBag, Reservoir

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-31

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