Duns Number:595138793
Device Description: Kits Contents : Catheter 9.5FR OD 3.22mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixa Kits Contents : Catheter 9.5FR OD 3.22mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Overneedle Introducer 16G OD 1.7mmx70mm, Dilator 10FR OD 3.33mm ID 0.96mm, Syringe 5ml & Scalpel.
Catalog Number
681735
Brand Name
CAREFLOW(TM) 5 LUMEN 9.5FR X 150MM
Version/Model Number
681735
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
742d8937-c292-4c13-a7cf-f887690914e6
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 29, 2016
Package DI Number
50886333617352
Quantity per Package
50
Contains DI Package
00886333617357
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |