Regard™ - RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Duns Number:134472476

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Regard™

Version/Model Number

243449

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080189,K080189

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

991b88b6-8e0f-4ae1-a888-29c503d1cf44

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

10326053104357

Quantity per Package

20

Contains DI Package

20326053104354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RESOURCE OPTIMIZATION & INNOVATION, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 558