Integral Drainage Set 910412

GUDID 10381780034193

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 Luer-lock connectors; 35 cm radiopaque straight ventricular catheter.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventricular cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 10381780034193
• NIH Device Record Key: d3a1bf3e-fcd7-4169-9661-8d86636c67e9
• Commercial Distribution Discontinuation: 2021-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integral Drainage Set
• Version Model Number: 910412
• Catalog Number: 910412
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034193 [Primary]
HIBCC	M2729104121 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924600

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-09
• Device Publish Date: 2015-10-01

On-Brand Devices [Integral Drainage Set]

• 10381780034209: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 10381780034193: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 30381780034180: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; smal
• 30381780034173: Two three-way Stopcock Protection Boxes.