Good Neighbor Pharmacy - A hand-held, battery-powered, electronic - Amerisourcebergen Drug Corporation

Duns Number:007914906

Device Description: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to to measure a patient's body temperature. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 30 seconds. This is a reusable device.

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More Product Details

Catalog Number

-

Brand Name

Good Neighbor Pharmacy

Version/Model Number

720

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

e699a097-8eaf-431d-af5f-4fe14ef993ea

Public Version Date

August 08, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10087701391306

Quantity per Package

4

Contains DI Package

20087701391303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"AMERISOURCEBERGEN DRUG CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 13