FDA.reportPublic FDA data

Pre-Filled Saline Flush Syringes,Sterile,10mL

Primary DI
00840117334533
Brand
Pre-Filled Saline Flush Syringes,Sterile,10mL
Company
Dynarex Corporation
Model
7059
Published
2024-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K231363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220060000
K231363000Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.2023-09-27NGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117334519PackageGS116In Commercial Distribution
00840117349810PackageGS130In Commercial Distribution
00840117334526PrimaryGS10
00840117334533Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117334519008401173345198401173345190840117334519
00840117349810008401173498108401173498100840117349810
00840117334526008401173345268401173345260840117334526
00840117334533008401173345338401173345330840117334533

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
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
00840117331341LabChoice Rigid Inoculation Loops, Transparent, Sterile, 1 ul431602025-03-14
00840117331365LabChoice Rigid Inoculation Loops, Blue, Sterile, 10ul431622025-03-21
00840117331372LabChoice Flexible Inoculation Loops, Blue, Sterile, 10 ul431632025-03-21
00840117333567LabChoice Cell Lifters, Sterile, 18 cm431702025-06-16
00840117333581LabChoice Cell Scraper, Sterile, 25 cm431712025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL431512025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL431522025-06-16
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31

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
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