AccessGUDID - DEVICE: Integral Drainage Set (10381780034186)

GUDID

Device Identifier (DI) Information

Brand Name: Integral Drainage Set
Version or Model: 910410
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 910410
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780034186
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube with attached clamp, check valve, and silicone band; graduated bag with hydrophobic vent filter, drip chamber, suspension string with adjustable clip; large diameter drainage collector; outlet tube with clamp, watertight cap and silicone band); a 360° three-way stopcock with two female Luer-lock connectors with cap and tubing terminating in a male Luer-lock connector with cap.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61796	Cerebrospinal fluid external drainage kit	A collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF) from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924600	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: Drainage Bag 700ml

Device Record Status

Public Device Record Key: 465fc8fa-e43a-45b0-9f5a-0ad40c05a83e
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: October 01, 2015