Chart, X-Ref Puritan Bennett 089028 - Chart, X-Ref Puritan Bennett 089028, 2.25" x 2", - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Chart, X-Ref Puritan Bennett 089028, 2.25" x 2", Thermal

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More Product Details

Catalog Number

141000

Brand Name

Chart, X-Ref Puritan Bennett 089028

Version/Model Number

Chart, X-Ref Puritan Bennett 089028 - 141000

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

06ab19e2-3722-4cd6-9351-2cbcd6fda890

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Additional Identifiers

Package DI Number

00817081025798

Quantity per Package

10

Contains DI Package

00817081025781

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