FDA.reportPublic FDA data

ACCUTRANS Disposable Pressure Monitoring Kit

Primary DI
08886483503748
Brand
ACCUTRANS Disposable Pressure Monitoring Kit
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
AT W/O IFU(BNS)
Catalog number
22-000940-02
Published
2026-05-04
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886483503748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886483503748088864835037488886483503748

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Contacts#

Phone, Email table
PhoneEmail
+6568592341ra-bpi@bioptimalg.com

Regulatory Flags#

DUNS number
595182247
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886483551640Thermodilution Catheter and AccessoriesTD1755HD21-000153-502026-05-20
08886483551657Thermodilution Catheter and AccessoriesTD2755NDF21-000202-452026-05-20
08886483551664Safewedge(TM) Relief Valve DeviceSafetywedge21-000212-012026-05-20
08886483500174Thermodilution Catheter and AccessoriesTD2604NXF21-000009-582026-05-04
08886483500181Thermodilution Catheter and AccessoriesTD2604NDXF21-000009-592026-05-04
08886483500372Thermodilution Catheter and AccessoriesTD2504NXF21-000046-432026-05-04
08886483500389Thermodilution Catheter and AccessoriesTD2504NDXF21-000046-442026-05-04
08886483501508Thermodilution Catheter and AccessoriesTD2704NDF21-000201-162026-05-04
08886483501515Thermodilution Catheter and AccessoriesTD2704NCXF21-000201-172026-05-04
08886483501546Thermodilution Catheter and AccessoriesTD2755NX21-000202-002026-05-04
08886483501553Thermodilution Catheter and AccessoriesTD2755NDF21-000202-012026-05-04
08886483501577Thermodilution Catheter and AccessoriesTD2755NDX21-000202-032026-05-04
08886483501584Thermodilution Catheter and AccessoriesTD2755NDPXF21-000202-042026-05-04
08886483502390BIOTRANS™ Pressure Monitoring KitsBTR4812-322-000813-232026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsEXTENSION TUBING SET22-000895-962026-05-04
08886483504455Embolectomy CatheterEL144023-000006-152026-05-04
08886483504486Embolectomy CatheterEL158023-000006-182026-05-04
08886483504516Embolectomy CatheterEL154023-000006-212026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBT-201BL-0003-0182026-05-04
08886483507166Bipolar Pacing CatheterBP2502-10BP-0002-0172026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL 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
H6719015960DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719020080DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719020110DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719020230DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23