AccessGUDID - DEVICE: External Drainage Set (10381780035527)

GUDID

Device Identifier (DI) Information

Brand Name: External Drainage Set
Version or Model: 910112A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 910112A
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780035527
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 External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. It also includes a Ventricular Catheter Accessory Kit.

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?
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
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Do not expose to temperatures exceeding 60 degrees Celsius (140 degrees Fahrenheit).

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Cylinder 75ml, Drainage Bag 500ml, Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length

Device Record Status

Public Device Record Key: 3e63347c-17f4-4225-93c3-2b4c36f258f2
Public Version Date: December 23, 2024
Public Version Number: 5
DI Record Publish Date: October 01, 2015