Duns Number:691795268
Device Description: This equipment is designed for low temperature storage of blood and blood products.
Catalog Number
-
Brand Name
PHCbi
Version/Model Number
MDF-U5312-PA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2021
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
KSE
Product Code Name
Refrigerator, Freezer, Blood Storage
Public Device Record Key
0e2edb20-4c3a-49fa-b049-8a88a2f4e328
Public Version Date
April 08, 2021
Public Version Number
3
DI Record Publish Date
April 25, 2018
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. | 16 |