BioStim NMS 2 - BIOMEDICAL LIFE SYSTEMS, INC.

Duns Number:116956807

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More Product Details

Catalog Number

KBSNMS2

Brand Name

BioStim NMS 2

Version/Model Number

NMS 2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031427,K031427

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

5cf06b62-769d-4bf7-8861-76dec84ead23

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10857771003207

Quantity per Package

48

Contains DI Package

00857771003200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"BIOMEDICAL LIFE SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80