Aneroid (82 etc) - PREMIUM ANEROID BP-LPK-BX - RASHMAN CORPORATION

Duns Number:078803608

Device Description: PREMIUM ANEROID BP-LPK-BX

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Aneroid (82 etc)

Version/Model Number

82-LPK

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082542

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

7f75d6e6-3e7a-4303-9bf4-8427701b43b0

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RASHMAN CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 633