FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450372115
Brand
Merit Medical®
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
10884450372118
Catalog number
682079/B
Published
2019-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K821450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821450000PRESSURE TUBING-ADULT & PEDIATRICGould, Inc.1982-05-25DRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884450372115PackageGS15In Commercial Distribution
10884450372118PrimaryGS10
00884450372111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445037211520884450372115
1088445037211810884450372118
00884450372111008844503721118844503721110884450372111

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595138793
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10884450321031Exacta™10884450321031680124/A2021-02-16
10884450321048Exacta™10884450321048680126/A2019-05-28
10884450321055Exacta™10884450321055680128/A2019-06-03
10884450321062Exacta™10884450321062680140/A2019-07-05
10884450389994Exacta™10884450389994680132/A2019-09-04
00886333610006SECALON T 18G/1.25 X 90MM MULT=25/2506810006810002016-09-24
00886333610020SECALON T 16G/1.70 X 130MM MULT=25/2506810026810022016-09-30
00886333610044SECALON T 16G/1.70 X 160MM MULT=25/2506810046810042016-09-23
00886333616121CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816126816122016-09-24
00886333616145CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816146816142016-09-24
00886333616152CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM6816156816152016-09-24
00886333616169CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816166816162016-09-24
00886333616176CAREFLOW(TM) 2 LUMEN 4FR X 60MM6816176816172016-09-24
00886333616183CAREFLOW(TM) 3 LUMEN 5FR X 100MM6816186816182016-09-24
00886333616190CAREFLOW(TM) 2 LUMEN 5FR X 60MM6816196816192016-09-24
00886333616206CAREFLOW(TM) 3 LUMEN 5FR X 60MM6816206816202016-09-24
00886333616220CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816226816222016-09-24
00886333616237CAREFLOW(TM) 1 LUMEN 2.5FR X 100MM6816236816232016-09-24
00886333616244CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816246816242016-09-24
00886333616251CAREFLOW(TM) 1 LUMEN 4FR X 60MM6816256816252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530695Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531715FloTrac JrBecton, Dickinson And CompanyDRS2026-09-04
00885403531722Acumen IQBecton, Dickinson And CompanyDRS2026-09-04
00885403531814FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531821FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531913FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531920FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531937FloTracBecton, Dickinson And CompanyDRS2026-09-04
00885403531845FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
00885403541974FLOTRAC, VAMPBecton, Dickinson And CompanyDRS2026-07-31
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
00887709089785ICU MedicalICU MEDICAL, INC.DRS2021-08-29
06945764400403AntmedShenZhen Antmed Co., LtdDRS2017-08-24
06945764404135AntmedShenZhen Antmed Co., LtdDRS2017-08-24
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