FDA.reportPublic FDA data

Demax

Primary DI
06943718225133
Brand
Demax
Company
Beijing Demax Medical Technology Co., Ltd.
Model
DHD0924
Published
2023-01-11
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222182000Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd2023-01-04DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16943718225130PackageGS150In Commercial Distribution
06943718225133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694371822513016943718225130
06943718225133069437182251336943718225133

GMDN Terms#

Term, Definition table
TermDefinition
Rotating pneumatic tourniquet systemAn automatic-cycling device assembly designed to prevent blood flow in one limb at a time, temporarily reducing the total blood flow volume with the intention of reducing the normal workload of the heart. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to regularly inflate the cuff, and an automatic control unit, i.e., a pressure indicator and regulator. By using a double cuff and automated valves the pressure point is regularly changed to avoid tissue damage or necrosis.

Regulatory Flags#

DUNS number
529725666
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06943718243014DemaxDBQ06102121S2025-02-06
06943718243038DemaxDBQ05102121S2025-02-06
06943718243045DemaxDBQ05162121S802025-02-06
06943718243052DemaxDBQ051021202025-02-06
06943718243069DemaxDBQ05162120802025-02-06
06943718243076DemaxDBQ051025202025-02-06
06943718243083DemaxDBQ06162121S802025-02-06
06943718243168DemaxDBQ05102120S2025-02-06
06943718243175DemaxDBQ05102120LS2025-02-06
06943718243182DemaxDBQ05162120S802025-02-06
06943718243199DemaxDBQ05162120LS802025-02-06
06943718243205DemaxDBQ05102120L2025-02-06
06943718243212DemaxDBQ05162120L802025-02-06
06943718243229DemaxDBQ05102520L2025-02-06
06943718243236DemaxDBQ05162520802025-02-06
06943718243243DemaxDBQ05162520L802025-02-06
06943718243250DemaxDBQ06102120S2025-02-06
06943718243267DemaxDBQ06102120LS2025-02-06
06943718243274DemaxDBQ06162120S802025-02-06
06943718243281DemaxDBQ06162120LS802025-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403294MillenniumAvalign Technologies, Inc.DXC2026-07-21
00810220800461Adler Instrument CompanyAdler, Inc.DXC2026-07-17
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16
00190776395605MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395698MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
10381780142935Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142942Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142959Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142966Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14
10381780142973Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONDXC2016-08-14