Vari-Fit Sterile Single Use

FDA UDI

Class I (US FDA UDI)

by Delfi Medical Innovations Inc

Identity

Trade Name: Vari-Fit Sterile Single Use FDA UDI
Generic Name: Tourniquet cuff, single-use FDA UDI
Device Name: 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. This part number is specifically used for Thigh and has dual port capabilities. FDA UDI
Model / Reference: 9-9400-003 FDA UDI
Description: 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. This part number is specifically used for Thigh and has dual port capabilities. FDA UDI

Identifiers

Primary DI / UDI-DI: M995994000031 FDA UDI
FDA Product Code: KCY FDA UDI
GMDN Term: Tourniquet cuff, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.5910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tourniquet cuff, single-use

Vari-Fit Sterile Single Use by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Delfi Medical Innovations Inc

Sources (1)

FDA UDI 3b619469-4b62-421b-aa0d-310683b9538c 34 fields · synced Jun 6, 2026