AccessGUDID - DEVICE: SHEATH INTRO POP KIT 8FR L5 MULT=5/50 (00886333601301)

GUDID

Device Identifier (DI) Information

Brand Name: SHEATH INTRO POP KIT 8FR L5 MULT=5/50
Version or Model: 680130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 680130
Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Primary DI Number: 00886333601301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595138793 *Terms of Use

Device Description: Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.35mm x ID 2.51mm x 10cm and Dilator; Guidewire 0.9 x 450mm; Introducer 1.4 x 70mm; Stopcock

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?
36079	Haemostasis valve	A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter

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: Catheter 8Fr

Device Record Status

Public Device Record Key: acbaea79-f8cb-468e-b22e-90b4185338ac
Public Version Date: March 05, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016