Duns Number:057827420
Device Description: CARDIOPAT, US LN 02050-US
Catalog Number
-
Brand Name
HAEMONETICS CARDIOPAT
Version/Model Number
02050-US
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
K053000
Product Code
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
297727fb-0ba9-4638-96ad-778c9e2304fc
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
February 07, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |