Duns Number:005083209
Device Description: Blood Extension Set
Catalog Number
2N3383
Brand Name
EXTENSION SET
Version/Model Number
2N3383
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
-
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
K210335,K210335
Product Code
BRZ
Product Code Name
Set, blood transfusion
Public Device Record Key
be50cb8e-411d-4503-bd69-02ca3186f567
Public Version Date
December 31, 2021
Public Version Number
1
DI Record Publish Date
December 23, 2021
Package DI Number
50085412653308
Quantity per Package
50
Contains DI Package
00085412653303
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |