Aneroid Kits - BASIC BP-BLK W/DUAL HEAD STETH-BX - RASHMAN CORPORATION

Duns Number:078803608

Device Description: BASIC BP-BLK W/DUAL HEAD STETH-BX

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More Product Details

Catalog Number

-

Brand Name

Aneroid Kits

Version/Model Number

A1-104

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

50d5cd51-4261-41d9-9c93-c15eae475bfa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

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