Duns Number:529121599
Device Description: Blood Bank Refrigerator
Catalog Number
HXC-629TB
Brand Name
Haier
Version/Model Number
HXC-629TB
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
KSE
Product Code Name
Refrigerator, Freezer, Blood Storage
Public Device Record Key
805fe08e-dfdf-42eb-9a89-7ea760dc7e36
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
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. | 40 |