BG 323 Pump - CME AMERICA LLC

Duns Number:002125419

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More Product Details

Catalog Number

-

Brand Name

BG 323 Pump

Version/Model Number

PUMP-BG323

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

baa036dc-06df-4866-b7a8-db98b6cd4cc8

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

January 16, 2017

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