BioMed Revived - BIOMEDICAL LIFE SYSTEMS, INC.

Duns Number:116956807

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More Product Details

Catalog Number

BRVE

Brand Name

BioMed Revived

Version/Model Number

Revived

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2019

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141299,K141299

Product Code Details

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Record Status

Public Device Record Key

34cbe67e-b40e-44bf-9ed1-773413653652

Public Version Date

February 19, 2021

Public Version Number

11

DI Record Publish Date

November 11, 2016

Additional Identifiers

Package DI Number

10857771003962

Quantity per Package

40

Contains DI Package

00857771003965

Package Discontinue Date

September 13, 2019

Package Status

Not 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