Duns Number:606034197
Device Description: For Use with PakPlus100
Catalog Number
404582
Brand Name
Specimen Diluent
Version/Model Number
404582
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
-
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
MYP
Product Code Name
Test,Platelet Antibody
Public Device Record Key
cfb7387b-7031-4be1-88b7-23d370f21d95
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 03, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 54 |
U | Unclassified | 36 |