JEWISH HOSP-DOUBLE LINE/BRIDGE SET - 2x 3cc transducers, 1x 20 drops, 60" tube Adset & - ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Duns Number:595138793

Device Description: 2x 3cc transducers, 1x 20 drops, 60" tube Adset & 2x 6" Pressure Tubing, each connected to

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More Product Details

Catalog Number

687341

Brand Name

JEWISH HOSP-DOUBLE LINE/BRIDGE SET

Version/Model Number

687341

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

e14e9aa8-2e81-470c-9b78-670091a665a6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

50886333673419

Quantity per Package

9

Contains DI Package

00886333673414

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