DEVICE: "X" SERIES PD CATHETER"X" SERIES PD CATHETER (00884908086775)

Device Identifier (DI) Information

"X" SERIES PD CATHETER"X" SERIES PD CATHETER
MBCA
Not in Commercial Distribution
MBCA
Medical Components, Inc.
00884908086775
GS1
January 29, 2021
1
038000253 *Terms of Use
BARBED LUER LOCK ADAPTORBARBED L
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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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 [?]
Premarket Submission Number Not Available/Not Released
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
No Device Sizes
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Device Record Status

c05d9256-92b8-4376-a011-59cab3f81127
February 05, 2021
2
August 25, 2018
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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
50884908086770 4 30884908086776 2021-01-29 Not in Commercial Distribution box
30884908086776 20 00884908086775 2021-01-29 Not in Commercial Distribution inner box
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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(215)256-4201
clinical@medcompnet.com
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