DEVICE: Natus® (00382830056977)
Device Identifier (DI) Information
Natus®
NT8501376
In Commercial Distribution
NT8501376
NATUS MEDICAL INCORPORATED
NT8501376
In Commercial Distribution
NT8501376
NATUS MEDICAL INCORPORATED
Pudenz Open-Ended Catheter With Slits
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, Central Nervous System And Components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153041 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
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) |
Device Record Status
769a22e8-f709-40c7-8c4e-1f77a645638d
February 20, 2025
3
April 17, 2020
February 20, 2025
3
April 17, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-356-0007
Madison.Helpdesk@Natus.com
Madison.Helpdesk@Natus.com