British Military, Rapid Infuser RI-2, 230V, 750 ml/min - BELMONT INSTRUMENT CORPORATION

Duns Number:078330362

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More Product Details

Catalog Number

-

Brand Name

British Military, Rapid Infuser RI-2, 230V, 750 ml/min

Version/Model Number

903-00039A-BM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K141654

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

353b4872-3238-47d1-8166-8363f8eb6426

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BELMONT INSTRUMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 163