CAREvent EMT 01CV0500

GUDID 07540195025042

CAREvent EMT hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individual

O-Two Medical Technologies Inc

Pulmonary resuscitator, pneumatic, reusable
Primary Device ID07540195025042
NIH Device Record Keycabdc0a5-79bf-434d-a505-7f25790b6b22
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAREvent EMT
Version Model Number01CV0500
Catalog Number01CV0500
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Device Dimensions

Weight0.45 Kilogram
Height2.9 Inch
Width2.5 Inch
Length5.5 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195025035 [Direct Marking]
GS107540195025042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

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 EMT]

07540195025066The CAREvent EMT kit contains a CAREvent EMT resuscitator, a pressure regulator and an aspirator
07540195025059The CAREvent EMT kit contains a CAREvent EMT resuscitator and a pressure regulator in moulded ca
07540195025042CAREvent EMT hand held automatic resuscitator is pneumatically powered, time/volume cycled venti

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.