Catalog Number

RMI-51130

Brand Name

ExSpiron 1Xi

Version/Model Number

Patient Cable, 8'

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

K130170,K130170

Product Code

BZK

Product Code Name

Spirometer, Monitoring (W/Wo Alarm)

Public Device Record Key

e319fb3e-6294-49fb-8c59-a37d1ab85dd4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00851540007093

Quantity per Package

1

Contains DI Package

00851540007017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case