Pedi-Fit Sterile Single Use

GUDID M995997000011

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. Single use tourniquet cuffs are intended for single use only.

Delfi Medical Innovations Inc

Tourniquet cuff, single-use

• Primary Device ID: M995997000011
• NIH Device Record Key: 052e865c-b46f-4475-8cc7-9db9d21d55f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-Fit Sterile Single Use
• Version Model Number: 9-9700-001
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +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	M995997000011 [Primary]
HIBCC	M995997000013 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• KCY: Tourniquet, Pneumatic

Sterilization

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

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 [Pedi-Fit Sterile Single Use]

• M995998000041: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995998000031: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995998000021: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995998000011: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995997000041: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995997000031: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995997000021: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995997000011: Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Avai
• M995609800004001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609800003001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609800002001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609800001001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609700004001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609700003001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609700002001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien
• M995609700001001: Delfi single use tourniquet cuffs are available in various models for pediatric and adult patien