SCHILLER - SpO2 Sensor for Maglife Serenity - SCHILLER MEDICAL

Duns Number:264351388

Device Description: SpO2 Sensor for Maglife Serenity

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More Product Details

Catalog Number

0-13-0040

Brand Name

SCHILLER

Version/Model Number

SpO2 Sensor wireless

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023195

Product Code Details

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Device Record Status

Public Device Record Key

356bcfa1-d944-4db1-8fc7-09c2afa850a5

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHILLER MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13