Little Martin's Drawer - Digital Thermometer_Blue - EBZNS HOLDINGS LLC

Duns Number:080521145

Device Description: Digital Thermometer_Blue

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More Product Details

Catalog Number

-

Brand Name

Little Martin's Drawer

Version/Model Number

BIT1611B

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

K110776

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

f813999b-57f9-476b-a867-a6ac09c15ff1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EBZNS HOLDINGS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8