Duns Number:029062325
Device Description: Cell Freeze Cryogenic Storage Container 250 mL Capacity
Catalog Number
CF-250
Brand Name
Cell Freeze
Version/Model Number
CF-250
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK100049,BK100049
Product Code
LPZ
Product Code Name
Container, Frozen Donor Tissue Storage
Public Device Record Key
227104b4-4963-4914-939d-cbd7509befc7
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2021
Package DI Number
00817827023514
Quantity per Package
40
Contains DI Package
00817827023019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| U | Unclassified | 7 |