VOCSN External Bacterial Filter PRT-00790-002

GUDID 00855573007198

VOCSN External Bacterial Filter

VENTEC LIFE SYSTEMS, INC.

In-exsufflator
Primary Device ID00855573007198
NIH Device Record Key727cba0f-7b59-4faf-a59a-faf6b09c76a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOCSN External Bacterial Filter
Version Model NumberPRT-00790-001
Catalog NumberPRT-00790-002
Company DUNS078758082
Company NameVENTEC LIFE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855573007013 [Primary]
GS100855573007198 [Package]
Contains: 00855573007013
Package: [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-31
Device Publish Date2017-11-11

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