Duns Number:002388445
Device Description: Upright Refrigerator, 25 cu.ft, Left hinge and chart recorder
Catalog Number
00927160
Brand Name
Follett
Version/Model Number
REF25-BB-L00CR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2017
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
a6b3f2bb-f080-4d4e-ab46-ae2dbd8993ce
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
December 29, 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. | 62 |