Antmed

Primary DI
06945764404203
Brand
Antmed
Company
ShenZhen Antmed Co., Ltd
Model
PT113203
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
DRSTransducer, Blood-Pressure, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091408000DISPOSABLE PRESSURE TRANSDUCERShenzhen Ant Hi-Tech Industrial Co., Ltd.2009-08-18DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945764404210PackageGS110In Commercial Distribution
06945764404203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945764404210069457644042106945764404210
06945764404203069457644042036945764404203

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip transducer, pressureA device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). 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
1
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
00885403531654Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
H6713000060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001010N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001020N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001220N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716004000N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719004920DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23