Petite-Fit (Small Adult), Reusable

GUDID M995981000011

Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. This cuff has dual port capabilities. Reusable tourniquet cuffs must be inspected before use. This product is subject to wear and deteriorates with use.

Delfi Medical Innovations Inc

Tourniquet cuff, reusable Tourniquet cuff, reusable Tourniquet cuff, reusable Tourniquet cuff, reusable

• Primary Device ID: M995981000011
• NIH Device Record Key: 8049dfaf-10d8-445d-a562-d3f6abf8e0c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Petite-Fit (Small Adult), Reusable
• Version Model Number: 9-8100-001
• Company DUNS: 251078945
• Company Name: Delfi Medical Innovations Inc
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 16047420600
• Email: info@delfimedical.com
• Phone: 16047420600
• Email: info@delfimedical.com
• Phone: 16047420600
• Email: info@delfimedical.com
• Phone: 16047420600
• Email: info@delfimedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M995981000011 [Primary]

FDA Product Code

• KCY: Tourniquet, Pneumatic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Petite-Fit (Small Adult), Reusable]

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• M995981000021: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995981000011: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995980000031: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995980000021: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995980000011: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995608100002001: Delfi reusable tourniquet cuffs are available in various models for extra small adult to large a
• M995608100001001: Delfi reusable tourniquet cuffs are available in various models for extra small adult to large a
• M995608000002001: Delfi reusable tourniquet cuffs are available in various models for extra small adult to large a
• M995608000001001: Delfi reusable tourniquet cuffs are available in various models for extra small adult to large a