Duns Number:184763290
Catalog Number
MAP802/A
Brand Name
PhD™
Version/Model Number
00884450160503
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
83def39a-6dc7-49ce-8b14-2e6fb5ff9764
Public Version Date
March 05, 2020
Public Version Number
2
DI Record Publish Date
May 28, 2019
Package DI Number
20884450160507
Quantity per Package
4
Contains DI Package
10884450160500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |