Duns Number:025460908
Device Description: OPT 125 Y-ADP W/LOW PROFILE RA & GW
Catalog Number
91400028
Brand Name
NAMIC
Version/Model Number
91400028
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"
Yes
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
K900652,K900652
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
33e69d17-00d8-4458-b32f-02184ef30e99
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 2021
Package DI Number
20193489069256
Quantity per Package
5
Contains DI Package
10193489069259
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |