FDA.reportPublic FDA data

Praxiject™ 0.9% NaCl

Primary DI
10682686004762
Brand
Praxiject™ 0.9% NaCl
Company
Medxl Inc
Model
3706US
Catalog number
3706US
Device description
20 mL of 0.9% Sodium Chloride Injection USP in a 20 mL syringe
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NGTSaline, Vascular Access Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGTSaline, Vascular Access FlushGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231754000Praxiject™ 0.9% NaClMedxl, Inc.2023-07-13NGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20682686004769PackageGS160In Commercial Distribution
30682686004766PackageGS16In Commercial Distribution
10682686004762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068268600476920682686004769
3068268600476630682686004766
1068268600476210682686004762

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobialA solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume20Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1.514.695.7474sales@medxl.com

Regulatory Flags#

DUNS number
259901445
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10682686005288Praxiject™ SP 0.9% NaCl3705-33705-32024-07-25
20682686005285Praxiject™ SP 0.9% NaCl3705-33705-32024-07-25
10682686004489Praxiject™ 0.9% NaCl37043US37043US2018-03-19
10682686004496Praxiject™ 0.9% NaCl3705CUS3705CUS2018-03-19
10682686004502Praxiject™ 0.9% NaCl37053US37053US2018-03-19
10682686004519Praxiject™ 0.9% NaCl37055US37055US2018-03-19
10682686004540Praxiject™ 0.9% NaCl3705-1US3705-1US2020-06-17
20682686004547Praxiject™ 0.9% NaCl3705-1US3705-1US2020-06-17
10682686004472Praxiject™ 0.9% NaCl3704US3704US2018-03-19
30682686004483Praxiject™ 0.9% NaCl37043US37043US2018-03-19
30682686004490Praxiject™ 0.9% NaCl3705CUS3705CUS2018-03-19
30682686004506Praxiject™ 0.9% NaCl37053US37053US2018-03-19
30682686004513Praxiject™ 0.9% NaCl37055US37055US2018-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860002238500Piccolo MedicalPiccolo Medical, Inc.NGT2026-05-06
08904379807920Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807937Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807975Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379808002Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807890Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807927Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807934Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807968Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
01890437980797Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379808009Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
00850063139472Neil Medical Group Neil Medical GroupNGT2025-12-08
00810192690114CerosRhino Medical Supply IncNGT2025-11-18
00810192690619CerosRhino Medical Supply IncNGT2025-11-18
00810192690053CerosRhino Medical Supply IncNGT2025-11-18
00810192690084CerosRhino Medical Supply IncNGT2025-11-18
00810192690121CerosRhino Medical Supply IncNGT2025-11-18
00810192690626CerosRhino Medical Supply IncNGT2025-11-18
00382903065929PosiFlushBECTON, DICKINSON AND COMPANYNGT2025-11-03
20612479279258McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2025-10-03
20612479279289McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2025-10-03
10704411017615AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
10704411017707AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
10704411017714AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017619AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017701AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017718AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
06971564461122GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564461139GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564464567ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14