DEVICE: Natus® (00382830056977)

Device Identifier (DI) Information

Natus®
NT8501376
In Commercial Distribution
NT8501376
NATUS MEDICAL INCORPORATED
00382830056977
GS1

1
081325959 *Terms of Use
10381780024309
Pudenz Open-Ended Catheter With Slits
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
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?
61159 Peritoneal/atrial cerebrospinal fluid catheter
A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JXG Shunt, Central Nervous System And Components
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153041 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
Device Size Text, specify: Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 120cm (47 1/4") (All dimensions nominal)
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Device Record Status

769a22e8-f709-40c7-8c4e-1f77a645638d
February 20, 2025
3
April 17, 2020
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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
Yes
No CLOSE

Customer Contact

[?]
1-800-356-0007
Madison.Helpdesk@Natus.com
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