CAREvent ALS 01CV3112

GUDID 07540195025127

CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an aspirator in moulded case with a Yankauer Scution Tip wit

O-Two Medical Technologies Inc

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID07540195025127
NIH Device Record Keyf770346e-0e13-47a3-a9d1-acb739a515df
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAREvent ALS
Version Model Number01CV3112
Catalog Number01CV3112
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195025127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-26

On-Brand Devices [CAREvent ALS]

07540195025165CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled venti
07540195025141CAREvent ALS kit 01CV3212 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp
07540195025134CAREvent ALS kit 01CV3200 contains a CAREvent ALS resuscitator and a pressure regulator in a car
07540195025127CAREvent ALS kit 01CV3112 contains a CAREvent ALS resuscitator, a pressure regulator, and an asp
07540195025110CAREvent ALS kit 01CV3100 contains a CAREvent ALS resuscitator and a pressure regulator. CAREven

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