Anorectal Manometry Catheter

GUDID 20627825001070

Kateter för Anorektal Tryckmätning

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic

• Primary Device ID: 20627825001070
• NIH Device Record Key: a00e5c77-8532-44dd-a1b5-a1e85538aa9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anorectal Manometry Catheter
• Version Model Number: CAT003
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• 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: 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	00627825001076 [Primary]
GS1	10627825001073 [Package]; Contains: 00627825001076; Package: [5 Units]; In Commercial Distribution
GS1	20627825001070 [Package]; Contains: 10627825001073; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963064

FDA Product Code

• FFX: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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