FDA.reportPublic FDA data

Amxor VacFlush Pre-Filled Normal Saline Flush Syringe

Primary DI
00850049248068
Brand
Amxor VacFlush Pre-Filled Normal Saline Flush Syringe
Company
Amxor Healthcare LLC
Model
AVF-10
Device description
AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site.
Published
2024-03-07
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
K220060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220060000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850049248065PackageGS140In Commercial Distribution
20850049248062PackageGS110In Commercial Distribution
00850049248068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004924806510850049248065
2085004924806220850049248062
00850049248068008500492480688500492480680850049248068

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Contacts#

Phone, Email table
PhoneEmail
7867861207e.colon@amxorhealthcare.com

Regulatory Flags#

DUNS number
124112849
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049248075AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248099AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248112AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
00850049248136AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248150AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248174AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248198AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248211AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13
00850049248235AMXOR Imperative 3-Layer SMS JacketAJ-CBL2024-03-13
00850049248259AMXOR Imperative 3-Layer SMS JacketAJ-PKXL2024-03-13
00850049248273AMXOR Imperative 3-Layer SMS JacketAJ-PPXL2024-03-13
00850049248297AMXOR Imperative 3-Layer SMS JacketAJ-CBXL2024-03-13
00850049248082AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248105AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248129AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
00850049248143AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248167AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248181AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248204AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248228AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682686005403AMSafe SP 0.9% NaClMedxl IncNGT2026-07-29
10682686005295Praxiject SP 0.9% NaClMedxl IncNGT2026-07-29
09347144017688Metier MedicalMETIER MEDICAL LTDNGT2026-06-29
09347144017695Metier MedicalMETIER MEDICAL LTDNGT2026-06-29
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