AccessGUDID - DEVICE: Natus® (00382830055277)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT903335A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT903335A
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830055277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780035381

Device Description: H-V LUMBAR VALVE SYSTEM, YELLOW

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?
61523	Lumboperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. 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 [?]
K161992	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: Closing Pressure Range (YELLOW) Horizontal: 85-125mmH2O / Vertical: 265-365mmH2O, Distal Cath. 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Lumb. Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5)

Device Record Status

Public Device Record Key: 7d48e306-9012-4901-b8d1-492329e31ae5
Public Version Date: February 20, 2025
Public Version Number: 3
DI Record Publish Date: April 03, 2020