FDA.reportPublic FDA data

GSO

Primary DI
06975803530679
Brand
GSO
Company
Group Supply Organization Medical Technology(Shanghai) Ltd
Model
GDTC3040SD
Device description
Disposable Tourniquet Cuff, Single Bladder, Dual Port, Sterile, Long Leg, 30X4 in
Published
2023-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
16975803530676PackageGS115In Commercial Distribution
26975803530673PackageGS14In Commercial Distribution
06975803530679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697580353067616975803530676
2697580353067326975803530673
06975803530679069758035306796975803530679

GMDN Terms#

Term, Definition table
TermDefinition
Arterial tourniquet, pneumaticAn inflatable cuff with fastening mechanism intended to be placed around a patient's limb (arm or leg) and pneumatically inflated from an integrated small gas cartridge to reduce and/or occlude arterial blood circulation to the distal portion of the limb during an emergency situation. It is typically used by emergency medical services (EMS) for emergency blood loss prevention. This is a single-use device.

Regulatory Flags#

DUNS number
554525912
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16975803530805GSOGCB15LF2025-11-30
16975803530812GSOGCB25LF2025-11-30
16975803530829GSOGCB35LF2025-11-30
16975803530836GSOGCB45LF2025-11-30
16975803530843GSOGCB25LFS2025-11-30
16975803530850GSOGCB45LFS2025-11-30
16975803530867GSOGCB25LFC2025-11-30
16975803530881GSOGC01B2025-11-30
26975803530802GSOGCB15LF2025-11-30
26975803530819GSOGCB25LF2025-11-30
26975803530826GSOGCB35LF2025-11-30
26975803530833GSOGCB45LF2025-11-30
26975803530840GSOGCB25LFS2025-11-30
26975803530857GSOGCB45LFS2025-11-30
26975803530864GSOGCB25LFC2025-11-30
16975803530874GSOGCB25LFB2025-11-30
26975803530888GSOGC01B2025-11-30
06975803530594GSOGDTC1840SS2023-03-06
06975803530600GSOGDTC2440SS2023-03-06
06975803530617GSOGDTC3040SS2023-03-06

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
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644090Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644106Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644113Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644120Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644137Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644144Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644151Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644168Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644175Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644182Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644199Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644205Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644212Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644229Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
96973521872753N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872777N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872272N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31
96973521872289N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31