FDA.reportPublic FDA data

Antmed

Primary DI
06945764403886
Brand
Antmed
Company
ShenZhen Antmed Co., Ltd
Model
CS0410
Published
2017-08-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072696000ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008-05-02DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945764403886PrimaryGS10
06945764403879Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945764403886069457644038866945764403886
06945764403879069457644038796945764403879

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999info@antmed.com

Regulatory Flags#

DUNS number
527221254
Device count
25
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945764400144Antmed1001022025-09-17
06945764400168Antmed1001102025-09-17
26945764400148Antmed1001022025-09-17
26945764400162Antmed1001102025-09-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
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