Duns Number:306032491
Device Description: Single use indwelling catheter for multiple subcutaneous injections. The indwelling cathet Single use indwelling catheter for multiple subcutaneous injections. The indwelling catheter must be used as described in the Instruction for Use.
Catalog Number
-
Brand Name
insuflon™
Version/Model Number
98-000-2612
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"
-
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
FOZ
Product Code Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Public Device Record Key
c59948a7-196e-485e-870c-71e9c35c98c6
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
05705244009486
Quantity per Package
200
Contains DI Package
05705244009479
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |