Refurbished BodyGuard® Vision Pole Mount Charger - CME AMERICA LLC

Duns Number:002125419

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More Product Details

Catalog Number

-

Brand Name

Refurbished BodyGuard® Vision Pole Mount Charger

Version/Model Number

150-313XVAR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 20, 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

K042696

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

ed737bfa-9512-4a0b-b270-fe28ea3e4129

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

September 15, 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