Normal Saline IV Flush Syringe MIS-1135

GUDID 30364253111359

Medefil Normal Saline IV Flush Syringe, 5mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are

MEDEFIL, INC.

Vascular catheter flush syringe
Primary Device ID30364253111359
NIH Device Record Keye3e01341-5a18-4942-8e69-d69f5ca3983d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNormal Saline IV Flush Syringe
Version Model Number5mL in 12mL syringe
Catalog NumberMIS-1135
Company DUNS016448669
Company NameMEDEFIL, INC.
Device Count60
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110364253111355 [Unit of Use]
GS130364253111359 [Primary]
GS150364253111353 [Package]
Package: box [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGTSaline, Vascular Access Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-04-21

On-Brand Devices [Normal Saline IV Flush Syringe]

30364253111359Medefil Normal Saline IV Flush Syringe, 5mL fill in 12mL syringe, Does not contain natural rubbe
30364253111335Medefil Normal Saline IV Flush Syringe, 3mL fill in 12mL syringe, Does not contain natural rubbe
30364253111304Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubb
30364253111250Medefil Normal Saline IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber
30364253111236Medefil Normal Saline IV Flush Syringe, 3mL fill in 6mL syringe, Does not contain natural rubber
50364253111223Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain natural rubber late

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