HealthSmart - BP Replacement Cuff - D-M-S HOLDINGS, INC.

Duns Number:062028220

Device Description: BP Replacement Cuff

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More Product Details

Catalog Number

04-240-006

Brand Name

HealthSmart

Version/Model Number

04-240-006

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

-

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

0e006fdb-b319-4a4b-b2e5-6fd90cc81173

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10767056240060

Quantity per Package

3

Contains DI Package

30767056240064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"D-M-S HOLDINGS, INC." 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. 206