Medefil Lock Flush Syringe, 1000 Unit/mL MIH-3352

GUDID 50364253333526

Medefil Heparin Lock Flush Syringe, 100 Unit/mL, 2.5mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

MEDEFIL, INC.

Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial
Primary Device ID50364253333526
NIH Device Record Keyc9f82305-63d9-48de-83c3-b1184cab6581
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedefil Lock Flush Syringe, 1000 Unit/mL
Version Model Number2.5mL in 6mL syringe
Catalog NumberMIH-3352
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 Usefalse
Lot Batchtrue
Serial Numbertrue
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
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
Phone630-682-4600
Emailpradeep@medefilinc.com
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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
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
GS110364253333528 [Unit of Use]
GS130364253333522 [Primary]
GS150364253333526 [Package]
Contains: 30364253333522
Package: carton [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZWHeparin, 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 Date2020-04-20
Device Publish Date2016-12-14

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