FDA.reportPublic FDA data

Antmed

Primary DI
06945764404685
Brand
Antmed
Company
ShenZhen Antmed Co., Ltd
Model
PT133208
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945764404685PackageGS110In Commercial Distribution
06945764404678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945764404685069457644046856945764404685
06945764404678069457644046786945764404678

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
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26945764400148Antmed1001022025-09-17
26945764400162Antmed1001102025-09-17
06945764401561Antmed5001012019-10-08
06945764400588Antmed2002032024-04-18
06945764411126Antmed200104B2024-04-18
06945764400700Antmed202301A2024-04-18
06945764411317Antmed4001042024-04-18
06945764411560Antmed5001112024-04-18
06945764412543AntmedHBR2002024-04-18
06945764416008Antmed6110182024-04-18
06945764416015Antmed6040302024-04-18
06945764416022Antmed6040452024-04-18
06945764416039Antmed6320502024-04-18
06945764418002Antmed6191502024-04-18
16945764431077Antmed6330502024-04-18
06945764400076Antmed1002012016-09-23
06945764400083Antmed1002022016-09-23
06945764400090Antmed1002032016-09-23
06945764400106Antmed1002042016-09-23
06945764400113Antmed1003012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709175980ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709175997ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709176000ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709128092ICU Medical, Inc.ICU MEDICAL, INC.DRS2025-04-08
08886483503854ACCUTRANS™ Disposable Pressure Monitoring SystemBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2025-01-22
00690103201079Acumen IQEdwards Lifesciences LLCDRS2024-09-23
50690103200930Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200954Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200978ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00690103201093Acumen IQEdwards Lifesciences LLCDRS2024-08-27
00690103201109ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00840619028152Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619037185Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619045104Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619065102Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619067212Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619097257Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709044838Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045255Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045293Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045460Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709070684Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709089280Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709121416Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127494Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127500Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127517Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127524Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127531Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127548Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20