HEPA Breathing Filter

GUDID 16959180703885

VR Medical Technology Co., Ltd.

Anaesthesia breathing circuit, single-use
Primary Device ID16959180703885
NIH Device Record Key77b6ed9a-3a4e-454a-8277-1965ead395a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEPA Breathing Filter
Version Model NumberVR012
Company DUNS420798349
Company NameVR Medical Technology Co., Ltd.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116959180703885 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2016-09-20

Devices Manufactured by VR Medical Technology Co., Ltd.

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16959180704219 - Closed Suction System2020-05-14
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16959180704332 - Closed Suction System2020-05-14

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