FDA.reportPublic FDA data

DTS-3000

Primary DI
18809315676332
Brand
DTS-3000
Company
DAESUNG MAREF CO.,LTD.
Model
DTC-D04
Device description
Double Cuff (DTC-D04) 1ea
Published
2021-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
18809315676332PackageGS18In Commercial Distribution
28809315676339PackageGS115In Commercial Distribution
38809315676336PackageGS130In Commercial Distribution
48809315676333PackageGS120In Commercial Distribution
58809315676330PackageGS128In Commercial Distribution
68809315676337PackageGS155In Commercial Distribution
08809315676335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880931567633218809315676332
2880931567633928809315676339
3880931567633638809315676336
4880931567633348809315676333
5880931567633058809315676330
6880931567633768809315676337
08809315676335088093156763358809315676335

GMDN Terms#

Term, Definition table
TermDefinition
Surgical pneumatic tourniquet systemA device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688817949
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
false
Donation ID number
true
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
08809802648494DVT-SERIESDS0312026-02-09
08809802648500DVT-SERIESDS0332026-02-09
18809802648491DVT-SERIESDS0312026-02-09
18809802648507DVT-SERIESDS0332026-02-09
08809802645301SP-1000SP10100-LL2025-12-19
08809802645318SP-1000SP10100-LX2025-12-19
08809802645325SP-1000SP10100-LZ2025-12-19
08809802645462SP-2000SP20100-LL2025-12-19
08809802645479SP-2000SP20100-LX2025-12-19
08809802645486SP-2000SP20100-LZ2025-12-19
08809802646131LX9maxLX9M100-LL2025-12-19
08809802646148LX9maxLX9M100-LX2025-12-19
08809802646155LX9maxLX9M100-LZ2025-12-19
08809802646810DVT-2600DVT3120-DT2025-12-19
08809802646858DVT-4000SDVT4100-DT2025-12-19
08809802645295SP-1000SP101002025-12-19
18809802645308SP-1000SP10100-LL2025-12-19
18809802645315SP-1000SP10100-LX2025-12-19
18809802645322SP-1000SP10100-LZ2025-12-19
08809802645332SP-1000SP10100-RL2025-12-19

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