PTS for BFR Generation 3 - Dual Channel System & Cuff Set

FDA UDI

Class I (US FDA UDI)

by Delfi Medical Innovations Inc

Identity

Trade Name: PTS for BFR Generation 3 - Dual Channel System & Cuff Set FDA UDI
Generic Name: Surgical pneumatic tourniquet system FDA UDI
Device Name: The Delfi PTS for BFR Gen 3 system is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. FDA UDI
Model / Reference: 9-2500-400BFR FDA UDI
Description: The Delfi PTS for BFR Gen 3 system is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. FDA UDI

Identifiers

Primary DI / UDI-DI: M99592500400BFR3 FDA UDI
FDA Product Code: KCY FDA UDI
GMDN Term: Surgical pneumatic tourniquet system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical pneumatic tourniquet system

PTS for BFR Generation 3 - Dual Channel System & Cuff Set by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Surgical pneumatic tourniquet system.

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DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
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LiveBand BFR — INNOVATION INSTITUTE, LLC · Class I
A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I

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 483d7818-04cf-44c3-af35-921d2d9139b6 34 fields · synced Jun 1, 2026