Duns Number:118793157
Device Description: Di Description
Catalog Number
-
Brand Name
Brand name
Version/Model Number
A40400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 05, 2018
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GGK
Product Code Name
PRODUCTS, RED-CELL LYSING PRODUCTS
Public Device Record Key
36f29ddc-1b21-4dce-9718-5f0e0bb4ee89
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 02, 2018
Package DI Number
30859952006018
Quantity per Package
601
Contains DI Package
10859952006014
Package Discontinue Date
June 05, 2018
Package Status
Not in Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 12 |