Duns Number:006261481
Device Description: CUSTOM PACK 10P21R CARDIOPLEGIA COI
Catalog Number
-
Brand Name
NA
Version/Model Number
10P21R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
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
Yes
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
K171308
Product Code
DWF
Product Code Name
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Public Device Record Key
991422df-5ce2-4354-ba22-50567e18fbd9
Public Version Date
January 04, 2019
Public Version Number
3
DI Record Publish Date
May 24, 2018
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |