Best Choice - 25 pack of probe covers. A device intended to be - VALU MERCHANDISERS COMPANY

Duns Number:868703513

Device Description: 25 pack of probe covers. A device intended to be used as a physical barrier between the pa 25 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.

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More Product Details

Catalog Number

-

Brand Name

Best Choice

Version/Model Number

753

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

Yes

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

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

4cd5451e-1426-415c-9954-37131bb83ed6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

40070038605155

Quantity per Package

24

Contains DI Package

20070038605151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"VALU MERCHANDISERS COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7