Duns Number:442126587
Catalog Number
-
Brand Name
KIDS
Version/Model Number
D100 M PHISIO + SAMPLING LINE
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
K061031,K061031
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
4fe2e878-7341-41db-a24f-a51b6fcb3724
Public Version Date
January 22, 2020
Public Version Number
4
DI Record Publish Date
May 13, 2015
Package DI Number
38033178109780
Quantity per Package
6
Contains DI Package
08033178109789
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 398 |
| 3 | A medical device with high risk that requires premarket approval | 78 |