CAREFLOW(TM) 1 LUMEN 7FR X 300MM - Kits Contents : Catheter 7FR OD 2.4mmx300mm; J - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: Kits Contents : Catheter 7FR OD 2.4mmx300mm; J guidewire OD 0.9mmx700mm, Secondary Fixatio Kits Contents : Catheter 7FR OD 2.4mmx300mm; J guidewire OD 0.9mmx700mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch Overneedle Introducer 16G OD 1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm & Syringe 5ml.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

681701

Brand Name

CAREFLOW(TM) 1 LUMEN 7FR X 300MM

Version/Model Number

681701

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Device Record Status

Public Device Record Key

a17113dc-7b0f-416d-8dea-d6a9401905e1

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50886333617017

Quantity per Package

50

Contains DI Package

00886333617012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Tray

"ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 392