Flow Control Tubing - GO MEDICAL INDUSTRIES PTY. LTD.

Duns Number:757634266

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More Product Details

Catalog Number

FCT50-90m-BRAUN

Brand Name

Flow Control Tubing

Version/Model Number

FCT 50mL/90mins

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K910007,K910007,K910007

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

e0fecc48-275d-446b-ba2e-70d664a0b01e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

9350902001560

Quantity per Package

840

Contains DI Package

09350902001546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton

"GO MEDICAL INDUSTRIES PTY. LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 6