100mm x 22m ECG Printer Paper (2/roll) - PAPER ROLLS, 100MM WIDE,ECG - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: PAPER ROLLS, 100MM WIDE,ECG

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More Product Details

Catalog Number

11240-000016

Brand Name

100mm x 22m ECG Printer Paper (2/roll)

Version/Model Number

11240

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

Issuing Agency

In GS1

Product Characteristics

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

ead7f982-e9af-49b9-96fe-3a5599330a1b

Public Version Date

May 01, 2019

Public Version Number

3

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHYSIO-CONTROL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 588