Health o meter professional - 1110KL with Pelstar Wireless Technology - Pelstar, LLC

Duns Number:037289290

Device Description: 1110KL with Pelstar Wireless Technology

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More Product Details

Catalog Number

-

Brand Name

Health o meter professional

Version/Model Number

1110KL-BT

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

FRI

Product Code Name

Scale, Stand-On, Patient

Device Record Status

Public Device Record Key

296010d8-d0a1-4bf8-afda-82fce2abc89c

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PELSTAR, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 239