Catalog Number

132-935-000

Brand Name

SIGNATURE CARE

Version/Model Number

2113077129

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

54f6d1c3-6f71-4252-bae5-b150e6692a31

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

10021130771292

Quantity per Package

24

Contains DI Package

00021130771295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner/Master Carton