JEWISH HOSPITAL-OPEN HEART SET - 4x 3cc transducers, each connects to a port of a - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: 4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connect 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.

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More Product Details

Catalog Number

686972

Brand Name

JEWISH HOSPITAL-OPEN HEART SET

Version/Model Number

686972

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

36c40bd1-c6f7-4199-afca-26dafcf40802

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

50886333669726

Quantity per Package

9

Contains DI Package

00886333669721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Bag

"ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 392