Duns Number:006261481
Device Description: PK 4J64R LARGE CIRCUIT
Catalog Number
-
Brand Name
NA
Version/Model Number
4J64R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2017
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)
-
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
8aa8173d-1f7d-4c16-99bc-73ff3ede49d2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 22, 2016
Package DI Number
20885074468475
Quantity per Package
4
Contains DI Package
00885074468471
Package Discontinue Date
August 28, 2017
Package Status
Not 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 |