InstaFlo

GUDID 20610075179743

Bowel Catheter System

HOLLISTER INCORPORATED

Faecal incontinence kit Faecal incontinence kit Faecal incontinence kit

• Primary Device ID: 20610075179743
• NIH Device Record Key: cbcb5d30-0641-459a-a777-2fe52857bea6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaFlo
• Version Model Number: 33016
• 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

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	00610075040070 [Primary]
GS1	20610075179743 [Package]; Contains: 00610075040070; Package: Case [4 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

Devices Manufactured by HOLLISTER INCORPORATED

• 10610075094759 - Adapt: 2024-01-24 Adapt CeraRing
• 30894689001912 - Restore: 2023-10-30 Calcium Alginate Dressing, Silver
• 30894689001929 - Restore: 2023-10-30 Calcium Alginate Dressing, Silver
• 30894689001936 - Restore: 2023-10-30 Calcium Alginate Dressing, Silver
• 20610075029574 - CalciCare: 2023-10-30 Calcium Alginate Silver Dressing
• 20610075029581 - CalciCare: 2023-10-30 Calcium Alginate Silver Dressing
• 20610075029598 - CalciCare: 2023-10-30 Calcium Alginate Silver Dressing
• 20610075177060 - Apogee: 2023-08-30 Catheter Insertion Kit