AccessGUDID - DEVICE: CODMAN HAKIM BACTISEAL HOLTER (10886704047384)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN HAKIM BACTISEAL HOLTER
Version or Model: NS5301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NS5301
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704047384
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing, .060 Inch Platform and BACTISEAL Catheters Operating Pressure: 10mm H2O Very Low Range Includes: BACTISEAL Ventricular Catheter 14cm, Stylet, Unitized BACTISEAL Peritoneal Catheter 120cm, Straight Connector, HOLTER Type "B" Connector, Right Angle Adapter, Priming Adapter and Information Manual

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
45694	Ventriculoperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 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 catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; 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 [?]
K053350	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
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit
Handling Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 88d42937-2814-4a83-bd7b-4a1378a06a98
Public Version Date: September 15, 2023
Public Version Number: 7
DI Record Publish Date: September 20, 2015