FDA.reportPublic FDA data

Antmed

Primary DI
06945764416022
Brand
Antmed
Company
ShenZhen Antmed Co., Ltd
Model
604045
Published
2024-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131770000PRESSURE CONNECTING TUBEShenzhen Ant Hi-Tech Industrial Co., Ltd.2014-02-26DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945764416022PackageGS150In Commercial Distribution
06945764417029PackageGS14In Commercial Distribution
06945764407181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945764416022069457644160226945764416022
06945764417029069457644170296945764417029
06945764407181069457644071816945764407181

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

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
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
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
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214083Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214120Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214168Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214243Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214380Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24