Rite Aid - A hand-held, battery-powered, electronic - 180 INNOVATIONS LLC

Duns Number:126646582

Device Description: A hand-held, battery-powered, electronic instrument designed to measure a patient's body t A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the temperal artery. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.

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More Product Details

Catalog Number

-

Brand Name

Rite Aid

Version/Model Number

KD-2201L.RA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2019

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

2616eec2-3e12-44cb-b8df-9fed17673f47

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

October 20, 2016

Additional Identifiers

Package DI Number

20809148323453

Quantity per Package

3

Contains DI Package

00809148323459

Package Discontinue Date

July 01, 2019

Package Status

Not in Commercial Distribution

Package Type

inner carton

"180 INNOVATIONS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19