FDA.reportPublic FDA data

JEWISH HOSPITAL-SINGLE ARTERIAL LINE

Primary DI
50886333669733
Brand
JEWISH HOSPITAL-SINGLE ARTERIAL LINE
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
686973
Catalog number
686973
Device description
A single 3cc transducer connected to a 20 drops, 60" tube AdSet. patient line is connected to a 12" Pressure Tube and a 72" Pressure tube via 3-way stopcock. It also includes a separately packed 3xmale & 1x Female fittings protective caps and a Label Set.
Published
2016-09-22
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
50886333669733PackageGS125In Commercial Distribution
00886333669738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633366973350886333669733
00886333669738008863336697388863336697380886333669738

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure monitoring tubing setA collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It 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.

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
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
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2024-07-10
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2024-06-19
10884450388164Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2023-03-03
10840935110002SunTech MedicalSUNTECH MEDICAL, INC.DXN2022-12-14
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2022-06-09
10884450385163Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-06-08
10884450323264Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-03-04
10884450619282Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450619299Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450621155Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450371777Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-18
10884450371739Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-10-12
10884450372781Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-07-21
10840935109662Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109679Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109686Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
G057IDBP8080IDEA HealthIDEA HEALTH LLCDXN2021-04-08
10884450544157Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-01-27
10193489012903MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012927MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012965MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012934MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10193489012972MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14