DEVICE: Argyle (10884521004085)

Device Identifier (DI) Information

Argyle
8811313010
In Commercial Distribution
8811313010
Covidien LP
10884521004085
GS1

1
058614483 *Terms of Use
Peritoneal Dialysis Catheter,Curl Cath, 2 Cuffs
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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.
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FDA Product Code

[?]
Product Code Product Code Name
FJS CATHETER, PERITONEAL, LONG-TERM INDWELLING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180485 000
K890288 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 62 Centimeter
Device Size Text, specify: No;
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Device Record Status

ca4a80a2-a74e-4f84-8e38-f0d0ae615e5e
September 17, 2020
5
September 28, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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