FDA.reportPublic FDA data

GSO

Primary DI
16975803530713
Brand
GSO
Company
Group Supply Organization Medical Technology(Shanghai) Ltd
Model
GDTC0825SS
Device description
Disposable Tourniquet Cuff, Single Bladder, Single Port, Sterile, Infant, 8X2.5 in
Published
2023-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16975803530713PackageGS115In Commercial Distribution
26975803530710PackageGS14In Commercial Distribution
06975803530716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697580353071316975803530713
2697580353071026975803530710
06975803530716069758035307166975803530716

GMDN Terms#

Term, Definition table
TermDefinition
Limb 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 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554525912
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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