60" Uni-Lim Adult Anesthesia Circuit

GUDID 10709078009423

60" Uni-Lim Adult Anesthesia Circuit, 10' x .060" ID M/M GSL, B/V Filter 3L not made with latex bag, In-Line Mini HMEF

WESTMED, INC.

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Primary Device ID10709078009423
NIH Device Record Key0fdee984-df0e-4e50-9f1c-1c55234f80ef
Commercial Distribution StatusIn Commercial Distribution
Brand Name60" Uni-Lim Adult Anesthesia Circuit
Version Model Number9617
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
GS100709078009426 [Primary]
GS110709078009423 [Package]
Contains: 00709078009426
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by WESTMED, INC.

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