AccessGUDID - DEVICE: Cleveland Multiport Ventricular Catheter Set (00860002624914)

GUDID

Device Identifier (DI) Information

Brand Name: Cleveland Multiport Ventricular Catheter Set
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00860002624914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005097598 *Terms of Use

Device Description: No description.

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":	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?
61798	Ventricular cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCA	Catheter, Ventricular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161731	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5e8ce1f9-d904-4ccf-ab3f-1c57a4e8ce3b
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: January 16, 2020