Reusable Temperature Probe - Reusable Temperature ProbePhilips - Orantech Inc.

Duns Number:544423370

Device Description: Reusable Temperature ProbePhilips Compatible,Adult skin, 3.0M

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More Product Details

Catalog Number

-

Brand Name

Reusable Temperature Probe

Version/Model Number

TS-PH-AS30

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173194

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

2bf19255-afaf-4b80-8480-98a2c1882e97

Public Version Date

September 06, 2022

Public Version Number

2

DI Record Publish Date

December 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORANTECH INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 158
2 A medical device with a moderate to high risk that requires special controls. 1473