HEMO POD ADAPTER SENSONOR 7PIN - DRAEGER MEDICAL SYSTEMS, INC.

Duns Number:788289952

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More Product Details

Catalog Number

-

Brand Name

HEMO POD ADAPTER SENSONOR 7PIN

Version/Model Number

MS23598

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070566

Product Code Details

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Device Record Status

Public Device Record Key

ad241415-0883-49a0-8f86-cd04acad4ef1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 02, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRAEGER MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 232