FDA.reportPublic FDA data

Antmed

Primary DI
26945764400162
Brand
Antmed
Company
ShenZhen Antmed Co., Ltd
Model
100110
Published
2025-09-17
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

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26945764400162PackageGS120In Commercial Distribution
06945764400168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2694576440016226945764400162
06945764400168069457644001686945764400168

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system syringeA component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in-barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. It is typically made of plastic materials and can be reused for several patients, e.g., up to five patients. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527221254
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945764400144Antmed1001022025-09-17
06945764400168Antmed1001102025-09-17
26945764400148Antmed1001022025-09-17
06945764400212AntmedPT1111032017-08-24
06945764400236AntmedPT1511032017-08-24
06945764400243AntmedPT1211032017-08-24
06945764400267AntmedPT1221032017-08-24
06945764400281AntmedPT1611032017-08-24
06945764400304AntmedPT1711032017-08-24
06945764400311AntmedPT1811032017-08-24
06945764400328AntmedPT1621032017-08-24
06945764400342AntmedPT1721032017-08-24
06945764400403AntmedPT1121032017-08-24
06945764400410AntmedPT1131032017-08-24
06945764400434AntmedPT1231032017-08-24
06945764400441AntmedPT1321032017-08-25
06945764400458AntmedPT1311032017-08-24
06945764400472AntmedPT1521032017-08-24
06945764400489AntmedPT1531032017-08-25
06945764400496AntmedPT1631032017-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065992NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066005NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066012NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05