IDEAL LIFE BP-Manager™ - BP Manager - Ideal Life Inc

Duns Number:205155174

Device Description: BP Manager

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More Product Details

Catalog Number

-

Brand Name

IDEAL LIFE BP-Manager™

Version/Model Number

BPM 0001

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060504,K060504,K060504,K060504,K060504

Product Code Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

Public Device Record Key

d9ed899a-b7fe-41c4-8d9a-8ef21c50e247

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

April 21, 2017

Additional Identifiers

Package DI Number

30804084000113

Quantity per Package

3

Contains DI Package

00804084000112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"IDEAL LIFE 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. 1