Duns Number:006261481
Device Description: PK 1G85R2 TABLE PACK
Catalog Number
-
Brand Name
Intersept® Custom Tubing Pack
Version/Model Number
1G85R2
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
K973011,K973011
Product Code
KFM
Product Code Name
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Public Device Record Key
a6c804f3-c338-4fb6-866b-af32d2130169
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2014
Package DI Number
20885074491282
Quantity per Package
5
Contains DI Package
00885074491288
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 |