Duns Number:006261481
Device Description: CUSTOM PACK 10H01R 12PK TEMP PORT
Catalog Number
-
Brand Name
NA
Version/Model Number
10H01R
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
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
K800178,K800178
Product Code
DWE
Product Code Name
TUBING, PUMP, CARDIOPULMONARY BYPASS
Public Device Record Key
634b0070-7c8b-4715-8944-947abbef5da4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 03, 2017
Package DI Number
20763000076256
Quantity per Package
12
Contains DI Package
00763000076245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |