AccessGUDID - DEVICE: Natus® (00382830056854)

GUDID

Device Identifier (DI) Information

Brand Name: Natus®
Version or Model: NT8501222
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NT8501222
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830056854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081325959 *Terms of Use
Previous DI: 10381780072294

Device Description: Pudenz Infant Cardiac Catheter (High Pressure)

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":	No
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?
61158	Atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where increased 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

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: Distal Tubing: 0.7 mm ID x 1.3 mm OD; Distal Tube Length: 9 cm; Proximal Tubing: 1.3 mm ID x 2.2mm OD; Total Length: 55 cm (22") (All dimensions nominal)

Device Record Status

Public Device Record Key: 5ee66c48-4d05-4bad-b45a-967853500d55
Public Version Date: February 20, 2025
Public Version Number: 3
DI Record Publish Date: April 17, 2020