Praxiject™ SP 0.9% NaCl 3705-3

GUDID 20682686005285

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 ID20682686005285
NIH Device Record Key39ff3ec7-9401-497e-b74e-a62581d55bdc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePraxiject™ SP 0.9% NaCl
Version Model Number3705-3
Catalog Number3705-3
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
Phone+1.514.695.7474
Emailsales@medxl.com

Device Dimensions

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
Total Volume10 Milliliter
Device Size Text, specify0
Total Volume10 Milliliter

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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110682686005288 [Primary]
GS120682686005285 [Package]
Contains: 10682686005288
Package: Box [30 Units]
In Commercial Distribution
GS130682686005282 [Package]
Package: Case [6 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-02
Device Publish Date2024-07-25

Devices Manufactured by Medxl Inc

20682686005285 - Praxiject™ SP 0.9% NaCl2024-08-0210 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
20682686005285 - Praxiject™ SP 0.9% NaCl2024-08-02 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
20682686004547 - Praxiject™ 0.9% NaCl2024-05-07 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
10682686004472 - Praxiject™ 0.9% NaCl2020-07-09 5 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
30682686004483 - Praxiject™ 0.9% NaCl2020-07-09 3 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
30682686004490 - Praxiject™ 0.9% NaCl2020-07-09 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
30682686004506 - Praxiject™ 0.9% NaCl2020-07-09 3 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
30682686004513 - Praxiject™ 0.9% NaCl2020-07-09 5 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

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