PTSii Personalized Tourniquet System, Twin

GUDID M995922005003

(Twin Channel, Single Port System) The Delfi PTS ii Portable Tourniquet 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.

Delfi Medical Innovations Inc

Surgical pneumatic tourniquet system
Primary Device IDM995922005003
NIH Device Record Keya3bd4c9b-57c0-4a6d-bb70-042339f33171
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTSii Personalized Tourniquet System, Twin
Version Model Number9-2200-500
Company DUNS251078945
Company NameDelfi Medical Innovations Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com
Phone+16047420600
Emailinfo@delfimedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM995922005003 [Primary]

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

Devices Manufactured by Delfi Medical Innovations Inc

M99592200250BFR3 - PTS BFR Tourniquet Instrument & Throwing Cuff Set 2026-01-22 The Delfi PTS BFR Tourniquet System is intended to be used by qualified medical professionals to exert enough pressure on the ar
M99597580018L1 - BFR Throwing Cuff, Reusable 2026-01-22 Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring quick-connect connectors and pa
M99597580018R1 - BFR Throwing Cuff, Reusable 2026-01-22 Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring quick-connect connectors and pa
M99597580021R1 - BFR Throwing Cuff, Reusable 2026-01-22 Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring quick-connect connectors and pa
M995979700181 - Matching Limb Protection Sleeves for Adaptive Cuffs2026-01-16 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching, and shearing
M995979700241 - Matching Limb Protection Sleeves for Adaptive Cuffs2026-01-16 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching, and shearing
M995979700301 - Matching Limb Protection Sleeves for Adaptive Cuffs2026-01-16 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching, and shearing
M995979700341 - Matching Limb Protection Sleeves for Adaptive Cuffs2026-01-16 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching, and shearing

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