FDA.report

Demax

Primary DI
16943718202063
Brand
Demax
Company
Beijing Demax Medical Technology Co., Ltd.
Model
DMK-T-W3(ON)
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16943718202063PackageGS140In Commercial Distribution
06943718202066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1694371820206316943718202063
06943718202066069437182020666943718202066

GMDN Terms

TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
529725666
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
false
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 DIBrandModelCatalogPublished
16943718225017DemaxDHD08122023-01-11
16943718225024DemaxDHD08142023-01-11
16943718225031DemaxDHD08162023-01-11
16943718225048DemaxDHD08182023-01-11
16943718225055DemaxDHD08202023-01-11
16943718225062DemaxDHD08222023-01-11
16943718225079DemaxDHD09122023-01-11
16943718225086DemaxDHD09142023-01-11
16943718225093DemaxDHD09162023-01-11
16943718225109DemaxDHD09182023-01-11
16943718225116DemaxDHD09202023-01-11
16943718225123DemaxDHD09222023-01-11
16943718225130DemaxDHD09242023-01-11
16943718225147DemaxDHD10122023-01-11
06943718225157DemaxDHD10142023-01-11
16943718225161DemaxDHD10162023-01-11
16943718225178DemaxDHD10182023-01-11
16943718225185DemaxDHD10202023-01-11
16943718225192DemaxDHD10222023-01-11
16943718225208DemaxDHD10242023-01-11

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