AccessGUDID - DEVICE: Attachable Suture Wing (00801741075148)

GUDID

Device Identifier (DI) Information

Brand Name: Attachable Suture Wing
Version or Model: 6660016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6660016
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741075148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: 9.5FR SUTURE WING PK

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:	No
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?
63723	Central venous catheterization kit, long-term	A collection of devices and materials intended for the long-term (>30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes an implantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KMK	DEVICE, INTRAVASCULAR CATHETER SECUREMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Catheter Gauge: 9.5 French

Device Record Status

Public Device Record Key: 355b0a0f-1a28-43d1-92ec-c1e4b75bcb10
Public Version Date: September 30, 2022
Public Version Number: 1
DI Record Publish Date: September 22, 2022