Heparin Lock Flush Syringe 1 unit/mL MIH-4422

GUDID 30364253444228

Medefil 1 Unit /mL Heparin Lock Flush Syringe, 2mL fill 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 ID30364253444228
NIH Device Record Key942ae73f-a757-494c-9668-9e8b32942156
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeparin Lock Flush Syringe 1 unit/mL
Version Model Number2 mL in 6mL Syringe
Catalog NumberMIH-4422
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
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
GS110364253444224 [Unit of Use]
GS130364253444228 [Primary]
GS150364253444222 [Package]
Package: box [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 Number5
Public Version Date2020-04-20
Device Publish Date2016-04-21

Devices Manufactured by MEDEFIL, INC.

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