FDA.reportPublic FDA data

Demax

Primary DI
16943718223365
Brand
Demax
Company
Beijing Demax Medical Technology Co., Ltd.
Model
DPBD62
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAVSyringe, Balloon Inflation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAVSyringe, Balloon InflationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140943000MASTRO PLUS BALLOON IN-DEFLATION DEVICEBeijing Demax Medical Technology Co.,Ltd2015-03-05MAV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16943718223365PackageGS120In Commercial Distribution
06943718223368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694371822336516943718223365
06943718223368069437182233686943718223368

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529725666
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
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
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2026-05-20
00884450021347DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
10884450021344DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-21
00884450021262DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
10884450021269DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-19
00884450021255DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
10884450021252DiamondTOUCH™Merit Medical Systems, Inc.MAV2025-06-05
00856877002742QL Locking Syringe DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2025-05-16
00884450830697Monarch®Merit Medical Systems, Inc.MAV2024-12-20
06943718223344DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223351DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223368DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223375DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223382DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
06943718223337DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223341DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223358DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223372DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
16943718223389DemaxBeijing Demax Medical Technology Co., Ltd.MAV2024-10-25
00884450851722Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851753Monarch®Merit Medical Systems, Inc.MAV2024-10-03
00884450851760Monarch®Merit Medical Systems, Inc.MAV2024-10-03
20197344104939NAMICMEDLINE INDUSTRIES, INC.MAV2024-09-09
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.MAV2024-08-06
20197344013781NAMICMEDLINE INDUSTRIES, INC.MAV2024-06-14
06947358563402Sunmed Inflation devicesSunny Medical Device (Shenzhen) Co., Ltd.MAV2023-09-25