Duns Number:801679200
Device Description: Red Blood Cell Exchange Set
Catalog Number
70700
Brand Name
COBE® Spectra
Version/Model Number
70700
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
K831004,K831004
Product Code
LKN
Product Code Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Public Device Record Key
dc4ac7b1-9e0f-4df9-a59d-c477ad819f65
Public Version Date
September 02, 2022
Public Version Number
3
DI Record Publish Date
June 07, 2021
Package DI Number
35020583707000
Quantity per Package
6
Contains DI Package
05020583707009
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 |