Disposable Anesthesia Breathing Circuit

GUDID 10709078009539

Anesthesia Circuit, Adult, 96" Expandable, GSE W/Cap, GSL 10' c .050" ID M/M, B/V Filter, 3L Not Made With Latex Breathing Bag, In-Line HMEF, Large Adult Mask, 900 Series

WESTMED, INC.

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Primary Device ID10709078009539
NIH Device Record Key16597be7-6176-4384-b9e3-2b9d54063ef4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Anesthesia Breathing Circuit
Version Model Number9110
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078009532 [Primary]
GS110709078009539 [Package]
Contains: 00709078009532
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [Disposable Anesthesia Breathing Circuit]

10709078006293UNI-LIM, 72' Adult, Mini HMEP GSL, LG Adult Mask 2L Not made with Latex Bag, Hose Clip GSE
10709078008617Anesthesia, Pediatric, 72"
10709078009539Anesthesia Circuit, Adult, 96" Expandable, GSE W/Cap, GSL 10' c .050" ID M/M, B/V Filter, 3L Not
10709078009522Anesthesia Circuit, Pediatric, 96" Expandable, GSE w/Cap, Parallel Wye, GSL 10' x .060" ID M/M 2
00709078009518Anesthesia Circuit, 96" Expandable, GSE w/Cap, Parallel Wye x/Port, GSL 10' x .060" ID M/M, 3L N
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