Duns Number:005083209
Device Description: Micro-Volume Extension Set
Catalog Number
2N3358
Brand Name
EXTENSION SET
Version/Model Number
2N3358
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
K192366,K192366
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
ad0b048b-c067-47c1-bc0b-7004197024f1
Public Version Date
October 19, 2022
Public Version Number
3
DI Record Publish Date
September 30, 2020
Package DI Number
50085412639340
Quantity per Package
50
Contains DI Package
00085412639345
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 |