VOCSN Patient Air Intake Filters PRT-01203-000

GUDID 00855573007532

VOCSN Patient Air Intake Filters, 3-Pack

VENTEC LIFE SYSTEMS, INC.

Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator
Primary Device ID00855573007532
NIH Device Record Key1731d180-88be-4dc4-aa19-0afa1de686f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOCSN Patient Air Intake Filters
Version Model Number3-Pack
Catalog NumberPRT-01203-000
Company DUNS078758082
Company NameVENTEC LIFE SYSTEMS, INC.
Device Count3
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
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007532 [Unit of Use]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]
GS100855573007952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
CBKVentilator, Continuous, Facility Use
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 Date2020-07-30
Device Publish Date2020-07-22

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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