FDA.reportPublic FDA data

Normal Saline IV Flush Syringe

Primary DI
30364253111250
Brand
Normal Saline IV Flush Syringe
Company
MEDEFIL, INC.
Model
5mL in 6mL Syringe
Catalog number
MIS-1125
Device description
Medefil Normal Saline IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
Published
2016-04-21
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

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
K091583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091583000MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGEMedefil, Inc.2010-01-28NGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50364253111254PackageGS116In Commercial Distribution
30364253111250PrimaryGS10
10364253111256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5036425311125450364253111254
3036425311125030364253111250
1036425311125610364253111256

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter flush syringeA sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-682-4600pradeep@medefilinc.com

Regulatory Flags#

DUNS number
016448669
Device count
60
Combination product
true
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
30364253222222Medefil Heparin Lock Flush Syringe, 10 Unit/mL2mL in 6mL SyringeMIH-22222016-12-14
30364253222253Heparin Lock Flush Syringe, 10 Unit/mL5mL in 6mL SyringeMIH-22252016-12-14
30364253222307Medefil Heparin Lock Flush Syringe, 10 Unit/mL10mL in 12mL SyringeMIH-22302016-12-14
30364253222352Heparin Lock Flush Syringe 10 Units/mL 5mL in 12mL syringeMIH-22352016-04-21
30364253222529Heparin Lock Flush Syringe, 10 Unit/mL2.5mL in 6mL syringeMIH-22522016-12-14
30364253333225Heparin Lock Flush Syringe 100 Unit /mL 2mL in 6mL Syringe MIH-33222016-12-14
30364253333256Heparin Lock Flush Syringe, 100 Unit/mL5mL in 6mL SyringeMIH--33252016-12-14
30364253333300Medefil Heparin Lock Flush Syringe, 100 Unit/mL10mL in 12mL SyringeMIH-33302016-12-14
30364253333522Medefil Lock Flush Syringe, 1000 Unit/mL 2.5mL in 6mL syringe MIH-33522016-12-14
30364253444211Medefil Heparin Lock Flush Syringe, 1 Unit/mL1mL in 6mL SyringeMIH-44212016-12-14
30364253444235Medefil Heparin Lock Flush Syringe, 1 Unit/mL3mL in 6mL SyringeMIH-44232016-12-15
30364253444303Medefil Heparin Lock Flush Syringe, 1 Unit/mL10mL in 12mL SyringeMIH-44302016-12-14
30364253444334Medefil Heparin Lock Flush Syringe, 1 Unit/mL3mL in 12mL SyringeMIH-44332016-12-14
30364253444358Medefil Heparin Lock Flush Syringe, 1 Unit/mL5mL in 12mL SyringeMIH-44352016-12-14
30364253444525Medefil Heparin Lock Flush Syringe, 1 Unit/mL2.5mL in 6mL syringeMIH-44522016-12-14
30364253222215Heparin Lock Flush Syringe 10 Units/mL1mL in 6mL syringeMIH-22212016-04-21
30364253222239Heparin Lock Flush Syringe 10 Units/mL 3mL in 6mL syringe MIH-22232016-04-21
30364253222338Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringe MIH-22332016-04-21
30364253333218Heparin Lock Flush Syringe 100 Units/mL 1mL in 6mL syringe MIH-33212016-04-21
30364253333232Heparin Lock Flush Syringe 100 Unit/mL 3mL in 6mL syringe MIH-33232016-04-21

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