Catalog Number

-

Brand Name

PREX

Version/Model Number

BT-A31-BT

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101387,K101387

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

45e4def7-d680-415f-964e-18ec21ea0152

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

26955647600053

Quantity per Package

120

Contains DI Package

16955647600049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case