BlackBox - Cellular weight scale with a large platform and - Blackbox Remote Patient Monitoring LLC

Duns Number:117652799

Device Description: Cellular weight scale with a large platform and high weight capacity

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More Product Details

Catalog Number

-

Brand Name

BlackBox

Version/Model Number

WS-501C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FRW

Product Code Name

Scale, Patient

Device Record Status

Public Device Record Key

4cdb39de-a09a-4fac-9c03-71dc29744f08

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

BB4B963WS501C1

Quantity per Package

4

Contains DI Package

B963WS501C0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"BLACKBOX REMOTE PATIENT MONITORING LLC" 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. 1