PENDING

Primary DI
30888277675906
Brand
PENDING
Company
MEDLINE INDUSTRIES, INC.
Model
EMZE060055
Catalog number
EMZE060055
Device description
SYRINGE,100U/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
OTC
false
Sterile
false
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
20888277675909PackageGS1100In Commercial Distribution
30888277675906PackageGS1600In Commercial Distribution
10888277675902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827767590920888277675909
3088827767590630888277675906
1088827767590210888277675902

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11

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
10888277675896PENDINGMEDLINE INDUSTRIES, INC.NZW2020-06-01
10888277675902PENDINGMEDLINE INDUSTRIES, INC.NZW2020-06-01
30888277675890PENDINGMEDLINE 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