Duns Number:080936069
Device Description: 14 Cu. Ft. High-Performance Laboratory Blood Bank Refrigerator. Features an intelligent m 14 Cu. Ft. High-Performance Laboratory Blood Bank Refrigerator. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of +4°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K212GDR-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.
Catalog Number
K212GDR-BB
Brand Name
K2 Scientific, LLC
Version/Model Number
K212GDRBB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
a829a7d2-3040-466c-83d4-941107fc6540
Public Version Date
October 28, 2021
Public Version Number
1
DI Record Publish Date
October 20, 2021
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. | 19 |