Duns Number:595138793
Device Description: Kits Contents : Catheter 5FR OD 1.75mmx300mm; J guidewire OD 0.9mmx700mm, Steel Needle Int Kits Contents : Catheter 5FR OD 1.75mmx300mm; J guidewire OD 0.9mmx700mm, Steel Needle Introducer 17G OD 1.4mmx70mm; Secondary Fixation Device, Dilator 8FR OD 2.69mm ID 0.96mm & Syringe 5ml.
Catalog Number
681681
Brand Name
CAREFLOW(TM) 1 LUMEN 5FR X 300MM
Version/Model Number
681681
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
1805eda3-158b-4b66-94ee-e58029d8a0c7
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
50886333616812
Quantity per Package
50
Contains DI Package
00886333616817
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 |