FDA.reportPublic FDA data

Neil Medical Group

Primary DI
00850063139472
Brand
Neil Medical Group
Company
Neil Medical Group
Model
1001
Device description
10ML PRIFILLED SYRINGE
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K202698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202698000Prefilled SyringeHangzhou Primecare Medical Co., Ltd.2020-12-15EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063139472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063139472008500631394728500631394720850063139472

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
122260045
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063139168NEIL MEDICALN100N1002024-08-07
00850063139175NEIL MEDICALN101N1012024-08-07
00850063139182NEIL MEDICALN102N1022024-08-07
00850063139373Neil Medical Group 2001-30ML2025-12-08
00850063139366Neil Medical Group 2001-10ML2025-12-08
00850063139434Neil Medical Group 20122025-12-08
00850063139441Neil Medical Group 20522025-12-08
00850063139458Neil Medical Group 20712025-12-08
00850063139465Neil Medical Group 20612025-12-08
00850063139199NEIL MEDICALN103N1032024-08-07
00850063139519Neil Medical Group 40132025-12-08
00850063139526Neil Medical Group 40122025-12-08
00850063139380Neil Medical Group 2004RED2025-12-08
00850063139397Neil Medical Group 2004PVC2025-12-08
00850063139403Neil Medical Group 2005-16FR2025-12-08
00850063139410Neil Medical Group 2005-18FR2025-12-08
00850063139427Neil Medical Group 2005-14FR2025-12-08
00850063139489Neil Medical Group 3002025-12-08
00850063139496Neil Medical Group 4024-1000ML2025-12-08
00850063139502Neil Medical Group 4024-500ML2025-12-08

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
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
06971564464574ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14