VOCSN O2 Low Pressure Inlet PRT-00981-000

GUDID 00855573007396

VOCSN O2 Low Pressure Inlet, 10-Pack

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator
Primary Device ID00855573007396
NIH Device Record Key6ab8e7c7-f9d8-4761-9124-c5d52bf9348b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOCSN O2 Low Pressure Inlet
Version Model Number10-Pack
Catalog NumberPRT-00981-000
Company DUNS078758082
Company NameVENTEC LIFE SYSTEMS, INC.
Device Count10
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
GS100855573007396 [Primary]
GS100855573007518 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-01-31
Device Publish Date2018-07-13

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