FDA.reportPublic FDA data

BlissCuff

Primary DI
96973521878618
Brand
BlissCuff
Company
Shenzhen Vistar Medical Supplies Co.,Ltd.
Model
DVT10T12
Device description
DVT Garment, Thigh Garment, S
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253386000DVT GarmentVistar Medical Supplies Co., Ltd.2026-06-25JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
96973521878618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9697352187861896973521878618

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, single-useA non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.

Regulatory Flags#

DUNS number
544328369
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
96973521878410BlissCuffDVT10C312026-07-22
96973521878427BlissCuffDVT10C322026-07-22
96973521878434BlissCuffDVT10C332026-07-22
96973521878441BlissCuffDVT10C342026-07-22
96973521878458BlissCuffDVT10C352026-07-22
96973521878465BlissCuffDVT10F312026-07-22
96973521878472BlissCuffDVT10F322026-07-22
96973521878489BlissCuffDVT10T312026-07-22
96973521878496BlissCuffDVT10T322026-07-22
96973521878502BlissCuffDVT10T332026-07-22
96973521878519BlissCuffDVT10T342026-07-22
96973521878526BlissCuffDVT10T352026-07-22
96973521878533BlissCuffDVT10C112026-07-22
96973521878540BlissCuffDVT10C122026-07-22
96973521878557BlissCuffDVT10C132026-07-22
96973521878564BlissCuffDVT10C142026-07-22
96973521878571BlissCuffDVT10C152026-07-22
96973521878588BlissCuffDVT10F112026-07-22
96973521878595BlissCuffDVT10F122026-07-22
96973521878601BlissCuffDVT10T112026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17