FDA.reportPublic FDA data

Disposable Tourniquet Cuff

Primary DI
16976514770542
Brand
Disposable Tourniquet Cuff
Company
Zhejiang Longyou Lande Medical Technology Co., Ltd.
Model
18"X4", 10-4610
Device description
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
Published
2023-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976514770542PackageGS110In Commercial Distribution
26976514770549PackageGS14In Commercial Distribution
06976514770545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697651477054216976514770542
2697651477054926976514770549
06976514770545069765147705456976514770545

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541228485
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
06976514770095Disposable Tourniquet CuffMTC1108;8''×2.75''2025-05-23
06976514770101Disposable Tourniquet CuffMTC2108;8''×2.75''2025-05-23
06976514770118Disposable Tourniquet CuffMTC1112;12''×4''2025-05-23
06976514770125Disposable Tourniquet CuffMTC2112;12''×4''2025-05-23
06976514770132Disposable Tourniquet CuffMTC1118;18''×4''2025-05-23
06976514770149Disposable Tourniquet CuffMTC2118;18''×4''2025-05-23
06976514770156Disposable Tourniquet CuffMTC1124;24''×4''2025-05-23
06976514770163Disposable Tourniquet CuffMTC2124;24''×4''2025-05-23
06976514770170Disposable Tourniquet CuffMTC1130;30''×4''2025-05-23
06976514770187Disposable Tourniquet CuffMTC2130;30''×4''2025-05-23
06976514770194Disposable Tourniquet CuffMTC1134;34''×4''2025-05-23
06976514770200Disposable Tourniquet CuffMTC2134;34''×4''2025-05-23
06976514770217Disposable Tourniquet CuffMTC2142;42''×4''2025-05-23
06976514770224Disposable Tourniquet CuffMTC1144;44''×4''2025-05-23
06976514770231Disposable Tourniquet CuffMTC1212;12''×5.5''2025-05-23
06976514770248Disposable Tourniquet CuffMTC1218;18''×5.5''2025-05-23
06976514770255Disposable Tourniquet CuffMTC1224;24''×5.5''2025-05-23
06976514770262Disposable Tourniquet CuffMTC2212;12''×5.5''2025-05-23
06976514770279Disposable Tourniquet CuffMTC2218;18''×5.5''2025-05-23
06976514770286Disposable Tourniquet CuffMTC2224;24''×5.5''2025-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106077MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106084MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106091MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106107MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106114MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106121MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106138MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106145MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106152MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106169MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106176MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106183MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106190MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106206MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106213MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106220MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106237MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106244MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106251MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106268MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106275MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106282MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106299MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106305MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15