PROVIDENCE HOSPITAL - ONE LINE SET - 1-way 20 drops, 60" Adset connected with a 3cc - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 2 1-way 20 drops, 60" Adset connected with a 3cc Transducer. The blood sampling line has a 24" Small Bore tube , a 1-way stopcock and another 6" small bore tube connect to the Septum Device. The other end of the device connects to a 3-way Red and a 3-way White stopcocks , a 6" Pressure Tubing which cis connected to a 5cc Restricted Syringe with touchguard stops at 3cc.

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More Product Details

Catalog Number

688075

Brand Name

PROVIDENCE HOSPITAL - ONE LINE SET

Version/Model Number

688075

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

b1434ee9-9bbd-498b-972a-cdecbeec9fd4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50886333680752

Quantity per Package

25

Contains DI Package

00886333680757

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