FDA.reportPublic FDA data

Suji BFR

Primary DI
05070000320403
Brand
Suji BFR
Company
SECONDPERSPECTIVE LTD.
Model
V2MDR-01
Device description
Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise.
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QGXGeneral Use Pneumatic Tourniquet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGXGeneral Use Pneumatic TourniquetGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05070000320403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05070000320403050700003204035070000320403

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
223208007
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017050485The Quick-T tourniquetFIRST CARE PRODUCTS LTDQGX2024-10-13
00850037100729Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-08-16
20850037100723Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-08-16
00850037100422Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
00850037100439Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
00850037100446Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
00850037100453Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
00850037100460Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
00850037100477Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100426Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100433Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100440Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100457Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100464Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
20850037100471Resilient Medical SolutionsResilient Medical Solutions, LLCQGX2023-05-22
07290017050300Quick-TFIRST CARE PRODUCTS LTDQGX2020-11-08