Mon-a-Therm - Cable 400TM For HP or Philips Monitors HP and - Covidien LP

Duns Number:058614483

Device Description: Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective o Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective owners.

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More Product Details

Catalog Number

-

Brand Name

Mon-a-Therm

Version/Model Number

502-0401A

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

K895875,K895875

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Device Record Status

Public Device Record Key

334f7475-a65a-46d7-9331-bf55b49f07b6

Public Version Date

May 04, 2022

Public Version Number

2

DI Record Publish Date

February 21, 2019

Additional Identifiers

Package DI Number

10884521706408

Quantity per Package

40

Contains DI Package

10884521169289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40