Duns Number:316153865
Device Description: Holding Clamp for Oxygenator QUADROX-i(D)Adult and Small Adult
Catalog Number
70106.4103
Brand Name
NA
Version/Model Number
Holding Clamp; QUADROX-i(D) Adult
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 29, 2020
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
-
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
K132829
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
31b401fd-8047-45f9-89ea-3f5cca010817
Public Version Date
March 02, 2020
Public Version Number
5
DI Record Publish Date
December 15, 2015
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |