Normnal Saline I.V. Flush Syringe - Medefil Normal Saline IV Flush Syringe, 1mL in - MEDEFIL, INC.

Duns Number:016448669

Device Description: Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use.

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More Product Details

Catalog Number

MIS-1121

Brand Name

Normnal Saline I.V. Flush Syringe

Version/Model Number

1mL 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

Yes

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

f6484569-805f-41b2-9242-5958bc7d4f00

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

50364253111216

Quantity per Package

16

Contains DI Package

30364253111212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton