AccessGUDID - DEVICE: Argyle (10884521004672)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888414029
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mozarc Medical US LLC

Primary DI Number: 10884521004672
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118997146 *Terms of Use

Device Description: Peritoneal Dialysis Catheter,Moncrief-Popovich Swan Neck Curl Cath, 2 Cuff,62.5 cm

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?
47086	Peritoneal dialysis catheter, 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. It is usually surgically or endoscopically implanted, percutaneously, for long-term use; it may be provided with Dacron cuffs to promote tissue ingrowth for the prevention of fluid leaks and bacterial penetration. It may be used in manual continuous ambulatory peritoneal dialysis (CAPD), automated continuous cyclic peritoneal dialysis, intraperitoneal chemotherapy, or to eliminate fluid overload in congestive heart failure. 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 [?]
K862046	000

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
Length: 62.5 Centimeter

Device Record Status

Public Device Record Key: dc6e710a-2ac1-412d-a0f4-b98bc9fbf386
Public Version Date: April 29, 2025
Public Version Number: 8
DI Record Publish Date: September 28, 2015