Duns Number:002144145
Device Description: CO2 Pressure Regulator
Catalog Number
EVRC67
Brand Name
ETHICON
Version/Model Number
EVRC67
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAN
Product Code Name
REGULATOR, PRESSURE, GAS CYLINDER
Public Device Record Key
cbfef3b7-0728-4615-bb32-51d674d43af0
Public Version Date
November 25, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
3 | A medical device with high risk that requires premarket approval | 4 |
U | Unclassified | 1 |