ActiFlo

GUDID 20610075179637

Bowel Catheter System, Drainable Kit

HOLLISTER INCORPORATED

Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit

• Primary Device ID: 20610075179637
• NIH Device Record Key: bd74976d-3e45-475a-9ae1-6cfbb5d14f61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiFlo
• Version Model Number: 32005
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• 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: false
• 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)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com

Device Dimensions

• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075179633 [Primary]
GS1	20610075179637 [Package]; Contains: 00610075179633; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083153

FDA Product Code

• KNT: TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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

On-Brand Devices [ActiFlo]

• 20610075179651: Bowel Catheter System, Disposable Kit
• 20610075179644: Bowel Catheter System, Disposable Kit
• 20610075179637: Bowel Catheter System, Drainable Kit
• 20610075179620: Bowel Catheter System, Drainable Kit