Medefil Heparin Lock Flush Syringe, 10 Unit/mL MIH-2222

GUDID 50364253222226

Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL 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 ID50364253222226
NIH Device Record Key9b92002a-cbf5-443f-9f84-9eccfd51bf16
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedefil Heparin Lock Flush Syringe, 10 Unit/mL
Version Model Number2mL in 6mL Syringe
Catalog NumberMIH-2222
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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
GS110364253222228 [Unit of Use]
GS130364253222222 [Primary]
GS150364253222226 [Package]
Contains: 30364253222222
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

On-Brand Devices [Medefil Heparin Lock Flush Syringe, 10 Unit/mL]

50364253222301Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 10mL in 12mL Syringe, Does not contain natural r
50364253222226Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL in 6mL Syringe, Does not contain natural rub

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