AccessGUDID - DEVICE: Natus® (00382830055864)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT902045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT902045
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830055864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780033400

Device Description: NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. 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 [?]
K152897	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: Operating Pressure Range (LOW): 40-80mmH2O, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Finned Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)

Device Record Status

Public Device Record Key: 316274c0-b817-4f6f-8d11-327224831d39
Public Version Date: February 20, 2025
Public Version Number: 3
DI Record Publish Date: April 03, 2020