Demax

Primary DI
16943718252020
Brand
Demax
Company
Beijing Demax Medical Technology Co., Ltd.
Model
DRD19
Published
2023-01-11
Public version status
Update
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
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
16943718252020PackageGS120In Commercial Distribution
06943718252023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694371825202016943718252020
06943718252023069437182520236943718252023

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529725666
Device count
1
DM exempt
false
Premarket exempt
false
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
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
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
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
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