Air-Charged Single Sensor Catheter

GUDID 10627825001035

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic Urodynamic manometric catheter, non-electronic

• Primary Device ID: 10627825001035
• NIH Device Record Key: 8eb86224-c8ca-4018-8cda-590cd83580da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air-Charged Single Sensor Catheter
• Version Model Number: CAT895
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)522-8743
• Email: vtcustomerservice@laborie.com
• Phone: +1(800)522-8743
• Email: vtcustomerservice@laborie.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825001038 [Primary]
GS1	10627825001035 [Package]; Contains: 00627825001038; Package: [10 Units]; In Commercial Distribution
GS1	20627825001032 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• FEN: DEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

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

[10627825001035]

Radiation Sterilization

[10627825001035]

Radiation Sterilization

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

Devices Manufactured by Laborie Medical Technologies Canada ULC

• 30627825007024 - Extension Set 2: 2022-07-04
• 20627825007294 - Extension Line, 60 cm: 2022-07-04
• 20627825007317 - Extension Line, 1500mm: 2022-07-04
• 20627825007324 - Extension Line, 15cm: 2022-07-04
• 20627825007348 - Extension Line, 150cm Blue: 2022-07-04
• 30627825007352 - Extension Line, 150cm Yellow: 2022-07-04
• 20627825007034 - Extension Set 3: 2022-07-04
• 30627825007307 - Extension Line, 90 cm: 2022-07-04