NA - M1193A Reusable Neonatal Hand/Foot SpO2 Sensor - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: M1193A Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m)

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More Product Details

Catalog Number

989803205881

Brand Name

NA

Version/Model Number

M1193A Reus Neo H-F SpO2 Sensor (1.5m)

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"

Yes

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

-

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

294a4d58-162e-411e-8b2f-285f8551bc6b

Public Version Date

August 15, 2022

Public Version Number

6

DI Record Publish Date

October 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 209