AccessGUDID - DEVICE: Natus® (00382830055635)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT9MZ110N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT9MZ110N
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830055635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780035848

Device Description: PERITONEAL CATHETER F7, 110 cm, WITH RADIOPAQUE STRIPE WITHOUT SLITS (O.D.: 2.3 mm x I.D. 1.1 mm)

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?
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 [?]
K971799	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: 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7)

Device Record Status

Public Device Record Key: a38cd5cd-98a2-4ba1-8f98-150c618766f5
Public Version Date: February 20, 2025
Public Version Number: 3
DI Record Publish Date: April 03, 2020