Catalog Number

703-10

Brand Name

SPIRO

Version/Model Number

703

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

f3b73c37-acfc-41f2-96dc-1e3818b0fb2c

Public Version Date

May 01, 2018

Public Version Number

1

DI Record Publish Date

March 31, 2018

Package DI Number

07350061231053

Quantity per Package

5

Contains DI Package

07350061231046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Zip-Lock Bag