Heparin Lock Flush Syringe 100 Units/mL

Primary DI
30364253333331
Brand
Heparin Lock Flush Syringe 100 Units/mL
Company
MEDEFIL, INC.
Model
3mL in 12mL syringe
Catalog number
MIH-3333
Device description
Heparin Lock Flush Syringe 100 Units/mL, 3 mL fill in 12 mL 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
NZWHeparin, Vascular Access Flush

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092491000MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESMedefil, Inc.2010-02-03NZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50364253333335PackageGS116In Commercial Distribution
30364253333331PrimaryGS10
10364253333337Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5036425333333550364253333335
3036425333333130364253333331
1036425333333710364253333337

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobialA solution which contains a low dose (e.g., 10 i.u. ) of an anticoagulant agent(s) [e.g., citrate and/or heparin] 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 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.

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
00363807600515PENDINGMEDLINE INDUSTRIES, INC.NZW2020-08-21
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30888277675890PENDINGMEDLINE INDUSTRIES, INC.NZW2020-06-01
30888277675906PENDINGMEDLINE INDUSTRIES, INC.NZW2020-06-01
20612479247714McKessonMCKESSON MEDICAL-SURGICAL INC.NZW2019-10-04
20612479247745McKessonMCKESSON MEDICAL-SURGICAL INC.NZW2019-10-04
20612479247776McKessonMCKESSON MEDICAL-SURGICAL INC.NZW2019-10-04
20612479247806McKessonMCKESSON MEDICAL-SURGICAL INC.NZW2019-10-04
30364253444235Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-15
50364253444239Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-15
30364253222222Medefil Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253222253Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253222307Medefil Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253222529Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253333225Heparin Lock Flush Syringe 100 Unit /mL MEDEFIL, INC.NZW2016-12-14
30364253333256Heparin Lock Flush Syringe, 100 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253333300Medefil Heparin Lock Flush Syringe, 100 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253333522Medefil Lock Flush Syringe, 1000 Unit/mL MEDEFIL, INC.NZW2016-12-14
30364253444211Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253444303Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253444334Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253444358Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-14
30364253444525Medefil Heparin Lock Flush Syringe, 1 Unit/mLMEDEFIL, INC.NZW2016-12-14
50364253222226Medefil Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
50364253222257Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
50364253222301Medefil Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
50364253222523Heparin Lock Flush Syringe, 10 Unit/mLMEDEFIL, INC.NZW2016-12-14
50364253333229Heparin Lock Flush Syringe 100 Unit /mL MEDEFIL, INC.NZW2016-12-14