PUBLIX - 30 Second Rigid Thermometer - PUBLIX SUPER MARKETS, INC.

Duns Number:006922009

Device Description: 30 Second Rigid Thermometer

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More Product Details

Catalog Number

84-358

Brand Name

PUBLIX

Version/Model Number

84-358

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041516,K041516,K041516

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

dcc05ddb-8e00-460d-8f3b-b14050e8dfba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20041415318735

Quantity per Package

144

Contains DI Package

10041415318738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER

"PUBLIX SUPER MARKETS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 17