Duns Number:595138793
Device Description: Kits Contents : Catheter 5FR OD 1.75mmx150mm; J guidewire OD 0.64mmx450mm, Steel Needle In Kits Contents : Catheter 5FR OD 1.75mmx150mm; J guidewire OD 0.64mmx450mm, Steel Needle Introducer 17G OD 1.4mmx70mm; Secondary Fixation Device, Dilator 6FR OD 2.03mm ID 0.66mm & Fenestrated Drape
Catalog Number
681692
Brand Name
CAREFLOW(TM) ULTRA BASIC 3 LUMEN 5FR X 150MM
Version/Model Number
681692
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
88d2f23d-39ac-4a8e-956d-4301b2b15964
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
50886333616928
Quantity per Package
50
Contains DI Package
00886333616923
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |