AccessGUDID - DEVICE: Prometra Catheter Revision Kit (00810335020105)

GUDID

Device Identifier (DI) Information

Brand Name: Prometra Catheter Revision Kit
Version or Model: 11830
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flowonix Medical, Inc.

Primary DI Number: 00810335020105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013518517 *Terms of Use

Device Description: The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A replacement catheter segment is provided with a catheter connector (and sleeve) to allow this segment to be attached to the existing catheter.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
47079	Spinal infusion/drainage catheter	A sterile flexible tube intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column for infusion of materials (typically anaesthetic or analgesic substances during surgery, labour, or delivery), and/or drainage of cerebrospinal fluid (CSF) and/or other fluids. Devices intended to assist catheter insertion (e.g., Tuohy needle, suture) may be included. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LKK	Pump, Infusion, Implanted, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080012	019

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
Special Storage Condition, Specify: Do not expose to direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c58e37c-137b-488f-a564-7fd2db38a357
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014