CIV - Fluid Delivery Set - EMED TECHNOLOGIES CORPORATION

Duns Number:622637544

Device Description: Fluid Delivery Set

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More Product Details

Catalog Number

CIV-032

Brand Name

CIV

Version/Model Number

CIV-032

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 06, 2020

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"

Yes

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

K935642,K935642

Product Code Details

Product Code

FPK

Product Code Name

Tubing, Fluid Delivery

Device Record Status

Public Device Record Key

ce46c6b4-428b-4f1b-a153-0bc46663b836

Public Version Date

April 07, 2021

Public Version Number

7

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

-

"EMED TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26