Pedi-Fit Sterile Single Use

Basic Information

• Brand Name: Pedi-Fit Sterile Single Use
• Primary DI: M995609700002001
• Version / Model: 60-9700-002-00
• Company Name: Delfi Medical Innovations Inc
• Labeler DUNS: 251078945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 6df5ef3b-fb98-488e-8004-017ca21b7811

Device Description

Delfi single use tourniquet cuffs are available in various models for pediatric and adult patients. Available in a selection of lengths and widths to facilitate a proper fit, and color coded for size identification. Single use tourniquet cuffs are intended for single use only.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	878.5910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35925	Tourniquet cuff, single-use	A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M995609700002001	HIBCC
Package	M995609700002003	HIBCC		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]