Ameritus Orange NeoFeed Pump System - Pump, charger, operations manual - CME AMERICA LLC

Duns Number:002125419

Device Description: Pump, charger, operations manual

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More Product Details

Catalog Number

-

Brand Name

Ameritus Orange NeoFeed Pump System

Version/Model Number

AEG-1PUMP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

Issuing Agency

In HIBCC

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

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

7f702b99-0a3a-45ed-af69-98dfbb0f719a

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CME AMERICA LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 125