Medichoice - Cable Adapter Ibp 11 Pin 4.0m Edwards Compatible - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Cable Adapter Ibp 11 Pin 4.0m Edwards Compatible Reusable Not Made With Natural Rubber Lat Cable Adapter Ibp 11 Pin 4.0m Edwards Compatible Reusable Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

Medichoice

Version/Model Number

CL8801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

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

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Device Record Status

Public Device Record Key

2ea99c32-4ffd-45b6-8a59-b8a9bd3c0b6d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1