Duns Number:006261481
Device Description: OXYGENATOR 61399400889 6PK 0800 ECMO
Catalog Number
-
Brand Name
ECMO
Version/Model Number
61399400889
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2014
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
-
Product Code
DTZ
Product Code Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Public Device Record Key
82e69802-fa70-4395-9f8e-627d87482d84
Public Version Date
October 26, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2014
Package DI Number
50613994008898
Quantity per Package
6
Contains DI Package
00613994008893
Package Discontinue Date
September 25, 2014
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 |