2-lumen Cystometry Pack

GUDID 10627825007549

with Rectal Split Balloon, 8F

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic

• Primary Device ID: 10627825007549
• NIH Device Record Key: 46e18292-e294-4297-acbe-6ee43f37c8d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2-lumen Cystometry Pack
• Version Model Number: 9021T1101
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825007535 [Primary]
GS1	10627825007549 [Package]; Contains: 00627825007535; Package: [25 Units]; In Commercial Distribution

FDA Product Code

• FEN: DEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

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

[10627825007549]

Ethylene Oxide

[10627825007549]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [2-lumen Cystometry Pack]

• 10627825007570: with Rectal Split Balloon with Introducer, 6F
• 10627825007549: with Rectal Split Balloon, 8F
• 10627825007518: with Rectal Split Balloon, 6F