BV Medical - Combo Kit: Orange Carrying Case & Aneroid - BV Medical

Duns Number:105932508

Device Description: Combo Kit: Orange Carrying Case & Aneroid Sphygmomanometer, Latex Free PVC

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More Product Details

Catalog Number

-

Brand Name

BV Medical

Version/Model Number

20-342-194-L

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

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

6f05f066-7fa0-44f9-9116-83fb384d8a6a

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 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