Heparin Lock Flush Syringe 1 Units /mL

Primary DI
30364253444259
Brand
Heparin Lock Flush Syringe 1 Units /mL
Company
MEDEFIL, INC.
Model
5mL in 6mL syringe
Catalog number
MIH-4425
Device description
Medefil 1 Units/mL Heparin 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
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
50364253444253PackageGS116In Commercial Distribution
30364253444259PrimaryGS10
10364253444255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5036425344425350364253444253
3036425344425930364253444259
1036425344425510364253444255

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
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

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Primary DI, Brand, Company table
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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