System M ® - Tube ID 3/16" x Wall 1/16" (OD 5/16") - SPECTRUM MEDICAL LIMITED

Duns Number:516398679

Device Description: Tube ID 3/16" x Wall 1/16" (OD 5/16")

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More Product Details

Catalog Number

3003-010-023

Brand Name

System M ®

Version/Model Number

Hct / SO2 Sensor

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

-

Prescription Use (Rx)

-

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

DRY

Product Code Name

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

a8212ab4-7ab3-427c-8370-d4f803659c8c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPECTRUM MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 111