Normal Saline IV Flush Syriinge - Medefil Normal Saline IV Flush Syringe , 2.5mL - MEDEFIL, INC.

Duns Number:016448669

Device Description: Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural rubber latex, Contents and its pathway are sterile, Single Use

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More Product Details

Catalog Number

MIS-1152

Brand Name

Normal Saline IV Flush Syriinge

Version/Model Number

2.5mL 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

e9df5db3-cc2d-491c-bc26-13dc20c0b124

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

50364253111520

Quantity per Package

16

Contains DI Package

30364253111526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton