Duns Number:006261481
Device Description: CUSTOM PACK 2E72R3 2PK BIO-PUMP
Catalog Number
-
Brand Name
NA
Version/Model Number
2E72R3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 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
K973011,K973011
Product Code
KFM
Product Code Name
Pump, blood, cardiopulmonary bypass, non-roller type
Public Device Record Key
5f2909ad-091b-49c3-b010-8664ef3c0dd1
Public Version Date
December 11, 2018
Public Version Number
4
DI Record Publish Date
May 29, 2016
Package DI Number
20643169776856
Quantity per Package
2
Contains DI Package
00643169776845
Package Discontinue Date
October 24, 2018
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 |