Duns Number:625272232
Device Description: Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed
Catalog Number
-
Brand Name
Cryostore Harvest Kit
Version/Model Number
CS750Y12S
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
BK030036,BK030036
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
b0bc9b37-8c8f-456b-8985-6de30247a3b6
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20816203020523
Quantity per Package
12
Contains DI Package
10816203020526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |