AccessGUDID - DEVICE: RetrO Catheter Repair Kit (00801741045110)

GUDID

Device Identifier (DI) Information

Brand Name: RetrO Catheter Repair Kit
Version or Model: PRRK5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRRK5
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741045110
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: RetrO Catheter Repair Kit

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":	Yes
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?
65099	Central venous catheter repair kit	A collection of devices intended to repair an in situ central venous catheter by replacing the damaged external (proximal) portion of the catheter. It includes the replacement proximal section of the catheter and devices associated with the adhesion of this section to the catheter portion remaining in situ (e.g., adhesive material, needle, syringe, sleeve); a complete central venous catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFK	Kit, repair, catheter, hemodialysis

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
No Device Sizes

Device Record Status

Public Device Record Key: 35205384-4662-4ec5-88cd-18de482bcd00
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: December 04, 2015