FDA.reportPublic FDA data

DTX(TM) PLUS DT-1272

Primary DI
50886333620161
Brand
DTX(TM) PLUS DT-1272
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682016
Catalog number
682016
Device description
a 1-way 60 drops, 60" tube Adset connected with a 3 cc transducer. Pressure tubings of 12" & 72" are on the patient line
Published
2016-09-23
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
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333620161PackageGS150In Commercial Distribution
00886333620166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362016150886333620161
00886333620166008863336201668863336201660886333620166

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
595138793
Device count
1
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
20884450372382Merit Medical®108844503723852019-01-16
20884450628304Merit Medical®B6821062024-12-07
20884450360631Meritrans DTXPlus®B6820012024-09-06
10884450330750Merit Medical®00884450330753684063/A2024-01-12
20884450387768Merit Medical®10884450387761682078/B2023-04-26
20884450388161Merit Medical®10884450388164682275/B2023-03-03
10884450330798Merit Medical®00884450330791684085/A2022-09-20
20884450321502Careflow™10884450321505681631/A2022-09-20
20884450387751Merit Medical®10884450387754682075/B2022-06-16
20884450385160Meritrans DTXPlus®10884450385163682034/B2022-06-08
20884450372085Merit Medical®10884450372088682077/B2022-04-26
00884450323267Meritrans DTXPlus®10884450323264683019/A2022-03-04
20884450619289Meritrans DTXPlus®10884450619282689887/B2022-02-28
20884450619296Safedraw™10884450619299689844/B2022-02-28
20884450621152Safedraw™10884450621155689883/B2022-02-28
20884450371774Meritrans DTXPlus®10884450371777682012/B2022-02-18
10884450361037Merit Medical®00884450361030684061/A2022-01-19
20884450321885Careflow™10884450321888681718/A2022-01-10
10884450361013Merit Medical®00884450361016684045/A2020-11-13
20884450320901Critikit™10884450320904680000/A2018-01-30

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Primary DI, Brand, Company table
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