Duns Number:080160207
Device Description: Field Recipient Blood Transfusion Kit
Catalog Number
4818-60002
Brand Name
Forward
Version/Model Number
4818-60002
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"
Yes
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
-
Product Code
POQ
Product Code Name
Blood Transfusion Kit
Public Device Record Key
713bf6a4-9971-4120-b285-7b6266057b12
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
00850015884009
Quantity per Package
12
Contains DI Package
00860000925310
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |