Duns Number:438860859
Device Description: MicroPort Smart Spot (IMV2+) / CPR4BR adapter
Catalog Number
KC861
Brand Name
Smart Spot with CPR4BR accessory
Version/Model Number
KC861
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
f2c0d222-b28a-4b18-8297-0c9867f6165d
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 |