Duns Number:938286804
Device Description: Thermo Scientific Revco RDE Series -86C, 600 Box Capacity , 208-230V/60Hz; ENERGY STAR cer Thermo Scientific Revco RDE Series -86C, 600 Box Capacity , 208-230V/60Hz; ENERGY STAR certified
Catalog Number
RDE60086MD
Brand Name
Thermo Scientific Revco
Version/Model Number
RDE60086MD
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
bce44d1e-c24b-43a0-8f52-52c0d265cbbc
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 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. | 255 |