AccessGUDID - DEVICE: CODMAN BACTISEAL (10886704041337)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN BACTISEAL
Version or Model: 82-3074
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 823074
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704041337
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 BACTISEAL Distal Catheter Kit with BACTISEAL Shunt System Contents: Distal Catheter 120cm (1), information manual (1)

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?
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 [?]
K102589	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
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit
Handling Environment Temperature: between 2 and 27 Degrees Celsius
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a8b1d8d-0406-478f-ab98-40baab73f7d3
Public Version Date: September 15, 2023
Public Version Number: 7
DI Record Publish Date: September 20, 2015