BV Medical - GemScope, Adult, Pink, Latex Free,I love nurses - BV Medical

Duns Number:105932508

Device Description: GemScope, Adult, Pink, Latex Free,I love nurses Chestpiece

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More Product Details

Catalog Number

-

Brand Name

BV Medical

Version/Model Number

30-510-214-Nurse

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"

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

LDE

Product Code Name

Stethoscope, Manual

Device Record Status

Public Device Record Key

6ef3fbe0-63f9-42eb-a67c-8cd3f7b235b8

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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