NA - Patient Monitor Interface Cable - Nihon-Kohden (5 - Medos International Sàrl

Duns Number:482661753

Device Description: Patient Monitor Interface Cable - Nihon-Kohden (5 Pin)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

826887

Brand Name

NA

Version/Model Number

826887

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 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)

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

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Device Record Status

Public Device Record Key

677c53e7-a596-414b-bc9e-e56e91e827ea

Public Version Date

September 01, 2022

Public Version Number

5

DI Record Publish Date

January 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDOS INTERNATIONAL SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 972
2 A medical device with a moderate to high risk that requires special controls. 6382
3 A medical device with high risk that requires premarket approval 20
U Unclassified 20