FDA UDI In Commercial Distribution 🇺🇸 United States

CAREvent EMT

DI: 07540195025059 · Model: 01CV1100 · O-Two Medical Technologies Inc
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CAREvent EMT
Primary DI
07540195025059
Version / Model
01CV1100
Catalog Number
01CV1100
Company Name
O-Two Medical Technologies Inc
Labeler DUNS
206449154
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-26
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
01a9346e-8b6c-42d7-b576-ca77a3de563f

Device Description

The CAREvent EMT kit contains a CAREvent EMT resuscitator and a pressure regulator in moulded case. The CAREvent EMT hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent EMT delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
13366 Pulmonary resuscitator, pneumatic, reusable

Identifiers

Type ID
Primary 07540195025059

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-40 – 60 Degrees Celsius