Catalog Number

140700

Brand Name

Chart Paper, Thermal, for Spirolab Spirometers

Version/Model Number

Chart Paper, Thermal, for Spirolab - 140700

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

Yes

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

DSF

Product Code Name

Recorder, Paper Chart

Public Device Record Key

6d67def0-e57f-4ec9-a189-2dde39ccfadc

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Package DI Number

00817081025712

Quantity per Package

2

Contains DI Package

00817081025705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Roll