PENDING EMZH60051

GUDID 00363807600515

DBD-SYRINGE,100U/ML HEPARIN 5ML IN 10ML

MEDLINE INDUSTRIES, INC.

Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

• Primary Device ID: 00363807600515
• NIH Device Record Key: db076159-5be0-4174-bb78-0be2cbdba09c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENDING
• Version Model Number: EMZH60051
• Catalog Number: EMZH60051
• Company DUNS: 025460908
• Company Name: MEDLINE INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com
• Phone: +1(800)633-5463
• Email: service@medline.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00363807600515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133446

FDA Product Code

• NZW: Heparin, vascular access flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [PENDING]

• 20888277675886: SYRINGE, SWABFLUSH,5/10ML, W/SWABCAP
• 30888277675906: SYRINGE,100U/ML HEPARIN 5ML IN 10ML
• 30888277675890: SYRINGE,10U/ML HEPARIN 5ML IN 10ML
• 10888277660748: SCREW, NON-LOCKING, 3.5 X 58MM
• 10888277660731: SCREW, NON-LOCKING, 3.5 X 56MM
• 10888277660724: SCREW, NON-LOCKING, 3.5 X 54MM
• 10888277660717: SCREW, NON-LOCKING, 3.5 X 52MM
• 10888277694835: CADDY, SNAP-OFF SCREWS
• 10888277694828: TUBE, DISTRACTION PIN, 2.7MM X 100MM
• 10888277694811: TUBE, DISTRACTION PIN, 2.5MM X 100MM
• 10888277694651: CADDY LID, FOOT PLATING, MTP FUSION
• 10888277694644: CADDY LID, FOOT PLATING, MIDFOOT
• 10888277694637: CADDY LID, FOOT PLATING, FLATFOOT
• 10888277694620: CADDY LID, FOOT PLATING, TEMP FIX PINS
• 10888277694613: CADDY LID, FOOT PLATING, CANN SCREWS
• 10888277694606: CADDY LID, FOOT PLATING, PLATE SCREWS
• 10888277694590: CADDY LID, CANN SCREWS, 6.5/7.0
• 10888277694583: CADDY LID, CANN SCREWS, 4.0/4.5
• 10888277694576: CADDY LID, CANN SCREWS, 3.0/3.5
• 10888277694569: CADDY LID, CANN SCREWS, 2.0/2.5
• 10888277692084: INSTRUMENT, COUNTERSINKING DRIVER HANDLE
• 10888277691308: PIN, TEMP FIX, THREADED, 1.6 X 15MM
• 10888277691285: PIN, TEMP FIX, THREADED, 1.6 X 10MM
• 10888277690875: PIN, TEMP FIX, SMOOTH MINI, 1.1 X 10MM
• 10888277675872: SYRINGE, SWABFLUSH, 3/10ML, W/SWABCAP
• 10888277675865: SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP
• 10888277674318: GUIDEWIRE, NON-THREADED, 1.1 X 50MM
• 10888277674219: PIN, TEMP FIX, SMOOTH, 1.1 X 15MM
• 10888277660854: SCREW, SNAP-OFF, 2.7 X 21MM
• 10888277660847: SCREW, SNAP-OFF, 2.7 X 19MM
• 10888277660830: SCREW, SNAP-OFF, 2.7 X 17MM
• 10888277660823: SCREW, SNAP-OFF, 2.7 X 15MM
• 10888277660816: SCREW, SNAP-OFF, 2.7 X 13MM
• 10888277660786: SCREW, SNAP-OFF, 2.0 X 14MM
• 10888277660779: SCREW, SNAP-OFF, 2.0 X 13MM
• 10888277660762: SCREW, SNAP-OFF, 2.0 X 12MM
• 10888277660755: SCREW, SNAP-OFF, 2.0 X 11MM
• 10888277660700: SCREW, CANN, HOOK PLATE, 4.0 X 50MM
• 10888277660694: SCREW, CANN, HOOK PLATE, 4.0 X 45MM
• 10888277362222: CO2 SAMPLING CANNULA,ADLT,GRN,7'O2,7'CO2
• 10888277139718: GUIDEWIRE, NON-THREADED, 1.4 X 150MM
• 10888277139701: GUIDEWIRE, NON-THREADED, 1.1 X 150MM
• 10888277139695: GUIDEWIRE, NON-THREADED, 0.9 X 150MM
• 10884389966143: CANNULA,ADULT,SOFT-TOUCH,7'TUBE,UC
• 10884389958865: TRAY, ASSEMBLY, 4.0/4.5 CANNULATED SCREW
• 10884389957394: TRAY, ASSEMBLY, 6.5/7.0 CANNULATED SCREW
• 10884389957387: TRAY, ASSEMBLY, 3.0/3.5 CANNULATED SCREW
• 10884389957370: TRAY, ASSEMBLY, 2.0/2.5 CANNULATED SCREW
• 10884389145838: CATHETER, CLOSED SUCTION, 8FR, ELBOW
• 10884389106099: TUBING,ADAPTER,15",HUMIDIFIER CONNECTOR