VOCSN Patient Air Intake Filters PRT-00977-000

GUDID 00855573007419

VOCSN Patient Air Intake Filters, 25-Pack

VENTEC LIFE SYSTEMS, INC.

Portable oxygen concentrator
Primary Device ID00855573007419
NIH Device Record Keyd6acf00e-b2fd-41d3-a9af-ed9723ff6511
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOCSN Patient Air Intake Filters
Version Model Number25-Pack
Catalog NumberPRT-00977-000
Company DUNS078758082
Company NameVENTEC LIFE SYSTEMS, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100855573007419 [Primary]
GS100855573007532 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-01-30

On-Brand Devices [VOCSN Patient Air Intake Filters]

00855573007419VOCSN Patient Air Intake Filters, 25-Pack
00855573007532VOCSN Patient Air Intake Filters, 3-Pack

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