8001 Series Esophageal/Rectal Temperature Probe - 8001 Series Esophageal/Rectal Temperature Probe - MEASUREMENT SPECIALTIES, INC.

Duns Number:029351079

Device Description: 8001 Series Esophageal/Rectal Temperature Probe

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More Product Details

Catalog Number

8001-063-412

Brand Name

8001 Series Esophageal/Rectal Temperature Probe

Version/Model Number

8001-063-412

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

9af78aa2-7908-45c3-ac07-f79c0e6d8913

Public Version Date

October 19, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2016

Additional Identifiers

Package DI Number

H29780010634122

Quantity per Package

10

Contains DI Package

H29780010634121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box

"MEASUREMENT SPECIALTIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25