Duns Number:806251398
Device Description: 4Fr x 50cm Single Lumen Synergy CT PICC IR Kit
Catalog Number
-
Brand Name
Synergy
Version/Model Number
A14-04150-IR
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
K101329,K101329,K101329
Product Code
LJS
Product Code Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Public Device Record Key
2c5ed1d7-18db-4084-a41a-e2752ef222ab
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
February 16, 2016
Package DI Number
10876604001050
Quantity per Package
5
Contains DI Package
00876604001053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 64 |