Catalog Number

MTSBRT015

Brand Name

BPL Respiratory Belt

Version/Model Number

MTSBRT015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K153026

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

9b2a1080-a2d6-46b6-b0fb-7f89ee3cace1

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-