FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450322783
Brand
Merit Medical®
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450322786
Catalog number
682274/A
Published
2020-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DXNSystem, measurement, blood-pressure, non-invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935782000DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIESOhmeda Medical1994-08-01DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450322783PackageGS110In Commercial Distribution
10884450322786PrimaryGS10
00884450322789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445032278320884450322783
1088445032278610884450322786
00884450322789008844503227898844503227890884450322789

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure transducer holderA device used to secure a pressure transducer used for invasive blood pressure measurement at a desired height. The holder can be fastened to (e.g., a bed or an operating table) and can be adjusted so that the transducer is at the same level as the heart of the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
5
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
false
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
10884450321505Careflow™10884450321505681631/A2022-09-20
10884450321567Careflow™108844503215672018-07-19
10884450321598Careflow™108844503215982018-07-19
10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
10884450322564Meritrans DTXPlus®108844503225642018-01-26
10884450323905Critiflo™108844503239052018-01-30
10884450326463Merit Medical®108844503264632018-01-26
10884450360467Merit Medical®108844503604672018-08-06
10884450360474Merit Medical®108844503604742018-12-13
10884450360481Merit Medical®108844503604812018-09-10
10884450360498Merit Medical®108844503604982018-03-19
10884450360504Merit Medical®108844503605042018-05-22
10884450360511Merit Medical®108844503605112018-09-17
10884450360535Meritrans DTXPlus®108844503605352018-12-03
10884450360689Meritrans DTXPlus®108844503606892018-02-14
10884450360702Meritrans DTXPlus®108844503607022018-11-06
10884450360764Meritrans DTXPlus®108844503607642018-04-11
10884450360825Meritrans DTXPlus®108844503608252018-05-01
10884450371753Meritrans DTXPlus®108844503717532019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27