Welch Allyn - IEM GmbH

Duns Number:344030150

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More Product Details

Catalog Number

-

Brand Name

Welch Allyn

Version/Model Number

ABPM 7100 HMS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2022

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"

-

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

a35e38ed-5d4b-494d-975f-4b6723ec380a

Public Version Date

May 31, 2022

Public Version Number

5

DI Record Publish Date

November 25, 2020

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