AccessGUDID - DEVICE: Natus® (00382830056250)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT951103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT951103
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830056250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780034247

Device Description: Y-LUMBAR CATHETER F5

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":	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61525	Lumboperitoneal shunt spinal catheter	A sterile implantable tube that is a component of a lumboperitoneal (LP) shunt intended to channel cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine in the management of elevated intracranial pressure due to increased CSF (hydrocephalus). It consists of a flexible tube fully implanted in the lumbar spine region and connected to a LP shunt valve. It is made of plastic materials and 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 [?]
K944595	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Tubing 720mm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 2 Arms 75mm Length each, F8-F5 Stepdown Connector

Device Record Status

Public Device Record Key: e83baf0c-1ef7-45a0-ad6a-6ef9a9ea4e14
Public Version Date: February 20, 2025
Public Version Number: 2
DI Record Publish Date: April 03, 2020