FDA.reportPublic FDA data

JEWISH HOSPITAL-OPEN HEART SET

Primary DI
50886333669726
Brand
JEWISH HOSPITAL-OPEN HEART SET
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
686972
Catalog number
686972
Device description
4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connects directly with a 20 drops, 60" Adset. The other 4 ports, each connects with a 6" Pressure Tubing with clamp. The 4 x 3cc transducers are individually connected to these tubings. The zeroing stopcock of transducer in port # 1 connects with a 12" Pressure tubing, with red tape for identification, It has a 60" &12" Pressure tubings connect to it via 2 separate 3-way red stopcocks. Port #2, transducer is connected with a 24" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port # 4, with its transducer connects to a Blue taped 24" pressure tubing and a 3-Way blue stopcock. Port # 5 connects with a transducer.
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
50886333669726PackageGS19In Commercial Distribution
00886333669721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633366972650886333669726
00886333669721008863336697218863336697210886333669721

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

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10884450321598Careflow™108844503215982018-07-19
10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
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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
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10884450360825Meritrans DTXPlus®108844503608252018-05-01
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