PENDING

Primary DI
10888277675896
Brand
PENDING
Company
MEDLINE INDUSTRIES, INC.
Model
EMZE050055
Catalog number
EMZE050055
Device description
SYRINGE,10U/ML HEPARIN 5ML IN 10ML
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K133446000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133446000HEPARIN LOCK / FLUSH SYRINGESExcelsior Medical Corporation2014-11-14NZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277675893PackageGS1100In Commercial Distribution
30888277675890PackageGS1600In Commercial Distribution
10888277675896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827767589320888277675893
3088827767589030888277675890
1088827767589610888277675896

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) [typically 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00363807600515PENDINGMEDLINE INDUSTRIES, INC.NZW2020-08-21
10888277675919MedlineMEDLINE INDUSTRIES, INC.NZW2020-08-21
10888277675902PENDINGMEDLINE INDUSTRIES, INC.NZW2020-06-01
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
50364253333250Heparin Lock Flush Syringe, 100 Unit/mLMEDEFIL, INC.NZW2016-12-14