AccessGUDID - DEVICE: Argyle (10884521004085)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8811313010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8811313010
Company Name: Covidien LP

Primary DI Number: 10884521004085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Peritoneal Dialysis Catheter,Curl Cath, 2 Cuffs

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
FJS	CATHETER, PERITONEAL, LONG-TERM INDWELLING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180485	000
K890288	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 62 Centimeter
Device Size Text, specify: No;

Device Record Status

Public Device Record Key: ca4a80a2-a74e-4f84-8e38-f0d0ae615e5e
Public Version Date: September 17, 2020
Public Version Number: 5
DI Record Publish Date: September 28, 2015