Catalog Number

RMI-51155

Brand Name

ExSpiron 1Xi

Version/Model Number

Nurse Call Module

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

BZK

Product Code Name

Spirometer, Monitoring (W/Wo Alarm)

Public Device Record Key

3d478747-5bda-40b1-83d4-b6c3c01f6a65

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

00851540007079

Quantity per Package

1

Contains DI Package

00851540007055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Mixed Case