Normal Saline IV Flush Syringe - Medefil Normal Saline IV Flush Syringe, 2mL in - MEDEFIL, INC.

Duns Number:016448669

Device Description: Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain natural rubbe Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single Use.

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More Product Details

Catalog Number

MIS-1122

Brand Name

Normal Saline IV Flush Syringe

Version/Model Number

2mL in 6mL Syringe

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"

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

K091583,K091583,K091583

Product Code Details

Product Code

NGT

Product Code Name

Saline, Vascular Access Flush

Device Record Status

Public Device Record Key

24cf4679-da18-4df2-a999-4cae6ffe9b45

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

50364253111223

Quantity per Package

16

Contains DI Package

30364253111229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton