N/A

GUDID 46923980108844

Silicone J-Circuit, Adult

GaleMed Xiamen Co., Ltd.

Ventilator breathing circuit, reusable
Primary Device ID46923980108844
NIH Device Record Key5b312e04-3a3f-42cc-8f84-16a5040ceaec
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberAB0090
Company DUNS527333326
Company NameGaleMed Xiamen Co., Ltd.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS126923980108840 [Primary]
GS146923980108844 [Package]
Contains: 26923980108840
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-04
Device Publish Date2024-05-27

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46923980104426Theta Circuit, 150cm

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