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DELFI MEDICAL INNOVATIONS INC.

Canada·CA-MF-000004434

Last updated September 17, 2026

Information

Country: Canada
Address: 1099, West 8th Avenue, Vancouver, Canada
Website: www.delfimedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 604 742 0600
PRRC Contact: Robert MacNeil
EUDAMED SRN: CA-MF-000004434
FDA FEI Number: 3003748933
DUNS Number: —

Catalogue (163)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Pedi-Fit Sterile Single Use	9-9800-004	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7975-153-00	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Pedi-Fit	9-7900-004	FDA UDI	Class I	Active
EMT Emergency & Military Tourniquet, Reusable	9-1100-001	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Easi-Fit	9-7920-024	FDA UDI	Class I	Active
Vari-Fit Sterile Single Use	9-9400-003	FDA UDI	Class I	Active
Vari-Fit Reusable	9-7350-011	FDA UDI	Class I	Active
Pedi-Fit Sterile Single Use	9-9700-004	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Vari-Fit	9-7920-001	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-153-00	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7975-105-00	FDA UDI	Class I	Active
PTS Roll Stand with Basket	9-2200-550	FDA UDI	Class I	Unknown
Matching Limb Protection Sleeves - Vari-Fit	9-7920-002	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-105-00	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-154-00	FDA UDI	Class I	Active
Easi-Fit Reusable	9-7500-034	FDA UDI	Class I	Active
Pedi-Fit Sterile Single Use	9-9700-001	FDA UDI	Class I	Active
Vari-Fit Sterile Single Use	9-9400-004	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-103-00	FDA UDI	Class I	Active
PTS for BFR Generation 3 - Dual Channel System & Cuff Set	9-2500-400BFR	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-156-00	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-155-00	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7975-157-00	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Easi-Fit BFR	9-7960-034	FDA UDI	Class I	Active
Easi-Fit Reusable	9-7600-052	FDA UDI	Class I	Active
PTS for BFR Tourniquet System & Cuff Set	9-2200-200BFR	FDA UDI	Class I	Active
Petite-Fit (Small Adult), Reusable	9-8000-002	FDA UDI	Class I	Active
Pedi-Fit Reusable	9-7700-005	FDA UDI	Class I	Active
PTS for BFR Generation 3 - Dual Channel System	9-2500-002BFR	FDA UDI	Class I	Active
Vari-Fit Reusable	9-7450-011	FDA UDI	Class I	Active
PTSii Personalized Tourniquet System (Red)	9-2200-001_R	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Easi-Fit BFR	9-7950-044	FDA UDI	Class I	Active
Easi-Fit BFR, Reusable	9-7550-044	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Petite-Fit	9-7910-001	FDA UDI	Class I	Active
Vari-Fit Reusable	60-7450-003-00	FDA UDI	Class I	Active
Vari-Fit Sterile Single Use	9-9400-002	FDA UDI	Class I	Active
Sterile Disposable Contour Cuff	60-7970-104-00	FDA UDI	Class I	Active
Pedi-Fit Reusable	9-7800-001	FDA UDI	Class I	Active
Pedi-Fit Reusable	9-7700-003	FDA UDI	Class I	Active
Petite-Fit (Small Adult), Reusable	9-8100-001	FDA UDI	Class I	Active
Petite-Fit (Small Adult), Reusable	9-8100-003	FDA UDI	Class I	Active
PTS Portable Basket	9-2200-501	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Pedi-Fit	9-7900-001	FDA UDI	Class I	Active
PTSii Personalized Tourniquet System	60-1000-101-00	FDA UDI	Class I	Active
Calibration Hose Set for PTS BFR, plastic Female	9-2200-610	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Easi-Fit	9-7920-044	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Easi-Fit BFR	9-7950-018	FDA UDI	Class I	Active
Petite-Fit (Small Adult), Reusable	9-8000-001	FDA UDI	Class I	Active
Vari-Fit Sterile Single Use	9-9400-011	FDA UDI	Class I	Active
Matching Limb Protection Sleeves - Vari-Fit	60-7920-001-00	FDA UDI	Class I	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 3, 2019	Z-1902-2020	—	terminated	Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
Apr 3, 2019	Z-1901-2020	—	terminated	Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.