RMS Precision Flow Rate TubingTM - Flow Control Infusion Tubing - REPRO MED SYSTEMS, INC.

Duns Number:048403299

Device Description: Flow Control Infusion Tubing

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More Product Details

Catalog Number

F0.5

Brand Name

RMS Precision Flow Rate TubingTM

Version/Model Number

F0.5

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

Yes

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

K933652,K933652

Product Code Details

Product Code

FRN

Product Code Name

Pump, infusion

Device Record Status

Public Device Record Key

c51051e0-b569-49c9-b002-f83a12312d8e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

10659443000022

Quantity per Package

50

Contains DI Package

00659443000025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"REPRO MED SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 99