AccessGUDID - DEVICE: "X" SERIES PD CATHETER"X" SERIES PD CATHETER (00884908143027)

GUDID

Device Identifier (DI) Information

Brand Name: "X" SERIES PD CATHETER"X" SERIES PD CATHETER
Version or Model: DMC20XC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DMC20XC
Company Name: Medical Components, Inc.

Primary DI Number: 00884908143027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 15F X 64CM X-SERIES15F X 64CM X- PERITONEAL DIALYSISPERITONEAL DI (CATHETER ONLY)(CATHETER ONLY)

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:	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?
47085	Peritoneal dialysis catheter, acute/chronic	A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane, and capable of being utilized for acute and chronic peritoneal dialysis. It may be surgically or endoscopically implanted, percutaneously, for long-term use; or percutaneously inserted for one-session dialysis. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FJS	Catheter, peritoneal, long-term indwelling

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: 80458afd-99df-40cb-88d7-844e8c572f21
Public Version Date: June 21, 2019
Public Version Number: 1
DI Record Publish Date: June 13, 2019