FDA.reportPublic FDA data

Demax

Primary DI
06943718247081
Brand
Demax
Company
Beijing Demax Medical Technology Co., Ltd.
Model
DQ06082120SN
Published
2023-04-15
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222184000Introducer Sheath KitsBeijing Demax Medical Technology Co.,Ltd2023-02-21DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26943718247085PackageGS130In Commercial Distribution
06943718247081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2694371824708526943718247085
06943718247081069437182470816943718247081

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Regulatory Flags#

DUNS number
529725666
Device count
1
Lot or batch
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
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDYB2023-09-01