British Military, Rapid Infuser, 230 V, 750ml/min - Fluid Warmer, 230V UNIT, 750ml/min - BELMONT INSTRUMENT CORPORATION

Duns Number:078330362

Device Description: Fluid Warmer, 230V UNIT, 750ml/min

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More Product Details

Catalog Number

-

Brand Name

British Military, Rapid Infuser, 230 V, 750ml/min

Version/Model Number

903-00001A-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

K091855

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

eae17793-f3d5-4236-aef9-5792234b15ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 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