Duns Number:438860859
Device Description: MicroPort CPR4BR accessory
Catalog Number
B10000
Brand Name
CPR4BR accessory
Version/Model Number
B10000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OSR
Product Code Name
Pacemaker/Icd/Crt Non-Implanted Components
Public Device Record Key
eb6770d9-1d57-4285-8df1-94db135b01f7
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |
| 3 | A medical device with high risk that requires premarket approval | 41 |