Meijer - Meijer Instant Ear Thermometer - MEIJER, INC.

Duns Number:006959555

Device Description: Meijer Instant Ear Thermometer

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More Product Details

Catalog Number

74-340

Brand Name

Meijer

Version/Model Number

74-340

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

afa25bad-506b-4498-bf49-0f8dff51540e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

10708820047720

Quantity per Package

24

Contains DI Package

30708820047724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"MEIJER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 45
U Unclassified 1