Duns Number:801679200
Device Description: Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set
Catalog Number
-
Brand Name
Quantum®
Version/Model Number
21020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KJF
Product Code Name
SYSTEM, SUSPENSION, CELL CULTURE
Public Device Record Key
8894d53b-758a-4053-b57a-9e7700c11f50
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
35020583210203
Quantity per Package
10
Contains DI Package
05020583210202
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |