AccessGUDID - DEVICE: CAREFLOW(TM) 2 LUMEN 5FR X 150MM (00886333616831)

GUDID

Device Identifier (DI) Information

Brand Name: CAREFLOW(TM) 2 LUMEN 5FR X 150MM
Version or Model: 681683
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 681683
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333616831
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: Consists of a 5FR, OD 1.75mm x 150mm, 2 Lumen catheter which packed together with a J guidewire OD 0.64mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mm x 70mm, Overneedle Introducer 18G 1.27mm x 60mm, Dialator 6FR OD 2.03mm ID 0.66mm and syringe 5ml.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5FR, OD 1.75mm x 150mm

Device Record Status

Public Device Record Key: 79bf5a52-39c9-49fa-addf-ce41ecae89fc
Public Version Date: March 20, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016