Praxiject™ 0.9% NaCl 3705-1US

GUDID 20682686004547

10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe

Medxl Inc

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Primary Device ID20682686004547
NIH Device Record Key419f2ac8-2e92-4988-b920-ffcd1d7f4932
Commercial Distribution StatusIn Commercial Distribution
Brand NamePraxiject™ 0.9% NaCl
Version Model Number3705-1US
Catalog Number3705-1US
Company DUNS259901445
Company NameMedxl Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com
Phone+1.514.695.7474
Emailsales@medxl.com

Device Dimensions

Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter
Device Size Text, specify0

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
GS110682686004540 [Primary]
GS120682686004547 [Package]
Contains: 10682686004540
Package: Carton [460 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 Number2
Public Version Date2024-05-07
Device Publish Date2020-06-17

On-Brand Devices [Praxiject™ 0.9% NaCl]

306826860045135 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
306826860045063 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
3068268600449010 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
306826860044833 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
106826860044725 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
2068268600454710 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe

Trademark Results [Praxiject]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRAXIJECT
PRAXIJECT
87227552 5492995 Live/Registered
MedXL Inc.
2016-11-05
PRAXIJECT
PRAXIJECT
77289384 3862391 Dead/Cancelled
MedXL inc.
2007-09-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.