BV Medical - Digital Thermometer, 10 Second, Rigid Tip, 5 - BV Medical

Duns Number:105932508

Device Description: Digital Thermometer, 10 Second, Rigid Tip, 5 Probe Covers

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More Product Details

Catalog Number

-

Brand Name

BV Medical

Version/Model Number

40-101-000-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

c166f97c-80de-40d8-8341-e9e2fca7f8ad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 19, 2016

Additional Identifiers

Package DI Number

00845821028570

Quantity per Package

10

Contains DI Package

00845821013071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BV MEDICAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 658
2 A medical device with a moderate to high risk that requires special controls. 163