NA - M1134A Adhesive-free Neonatal/Infant/Adult - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: M1134A Adhesive-free Neonatal/Infant/Adult

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More Product Details

Catalog Number

989803205861

Brand Name

NA

Version/Model Number

SPO2 SPU Adhsve-free Wrap Sensor M1134A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

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

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

02dae95f-cb55-4daa-bd8a-400b38a3512d

Public Version Date

August 15, 2022

Public Version Number

5

DI Record Publish Date

March 15, 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