NEODOT - Non-Contact Infrared Thermometer - Slv Pharmaceuticals LLC

Duns Number:081225162

Device Description: Non-Contact Infrared Thermometer

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

NEODOT

Version/Model Number

CK-T1502

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

K193253

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

a7dc56b6-50e9-40a0-85f9-584db257acb3

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

November 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SLV PHARMACEUTICALS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 34