Stabil-O-Graph-cuff - IEM GmbH

Duns Number:344030150

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More Product Details

Catalog Number

-

Brand Name

Stabil-O-Graph-cuff

Version/Model Number

M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2021

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

-

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

ad20a3df-2873-48a6-a47b-fc54ba317875

Public Version Date

September 10, 2021

Public Version Number

5

DI Record Publish Date

November 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IEM GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 60