Chart Paper, Thermal, for SDI Astra Touch - Chart Paper, Thermal, for SDI Astra Touch - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Chart Paper, Thermal, for SDI Astra Touch

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More Product Details

Catalog Number

140750

Brand Name

Chart Paper, Thermal, for SDI Astra Touch

Version/Model Number

Chart Paper, Thermal, for SDI Astra Touch - 140750

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DSF

Product Code Name

Recorder, Paper Chart

Device Record Status

Public Device Record Key

22b3e07c-5914-466d-a7a2-522798c20187

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Additional Identifiers

Package DI Number

00817081025736

Quantity per Package

10

Contains DI Package

00817081025729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Roll

"A-M SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 126