EZ-Pak™ Kit

GUDID 20613994936213

CATH 5A0092 SS 5PK 5F EZ W/STR PG.038INP

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20613994936213
• NIH Device Record Key: da97cb91-feb9-43a6-a650-6ac4aae222ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Pak™ Kit
• Version Model Number: 5A0092
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store catheters in a cool, dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters in a cool, dry area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994936219 [Primary]
GS1	20613994936213 [Package]; Contains: 00613994936219; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932092

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-03

On-Brand Devices [EZ-Pak™ Kit]

• 20613994941200: CATHETER 558500 PF 5PK KIT 6F BTO EZ PK
• 20613994941163: CATHETER 558453 PF 5PK KIT 7F ST EZ-PAK
• 20613994940715: CATHETER 558450 PF 5PK KIT 7F ST EZ-PAK
• 20613994940692: CATH 558448 PF 5PK KIT 6F ST XT EZPAK
• 20613994940685: CATHETER 558447 PF 5PK 6F ST EZ-PAK
• 20613994940661: CATH 558445 PF 5PK KIT 6F ST XT EZPAK
• 20613994940654: CATHETER 558443 PF 5PK 6F ST EZ-PAK
• 20613994940630: CATHETER 558420 PF 5PK 6F ST EZ-PAK
• 20613994940623: CATHETER 558419 PF 5PK 6F EZ PK
• 20613994940616: CATH 558418 PF 5PK KIT 6F ST XT EZPAK
• 20613994940579: CATHETER 554902 PF 5PK KIT 7F ST EZ-PAK
• 20613994940302: CATH 6A0107 SS 5PK6F EZ W/145 6SH.038INP
• 20613994940227: CATH 858448 PF 5PK KIT 6F ST XT EZPAK
• 20613994940210: CATHETER 858447 PF 5PK 6F ST EZ-PAK
• 20613994940197: CATH 858445 PF 5PK KIT 6F ST XT EZPAK
• 20613994940180: CATHETER 858443 PF 5PK 6F ST EZ-PAK
• 20613994940166: CATHETER 858420 PF 5PK 6F ST EZ-PAK
• 20613994940159: CATHETER 858419 PF 5PK 6F EZ PK
• 20613994940142: CATH 858418 PF 5PK KIT 6F ST XT EZPAK
• 20613994939870: CATH 6A0106 SS 5PK6F EZ W/145 6SH.035INP
• 20613994939863: CATH 6A0105 SS 5PK6F EZ W/STRXT 6SH .038
• 20613994939856: CATH 6A0104 SS 5PK6F EZ W/STR XT 6SH.035
• 20613994939825: CATH 6A0101 SS 5PK6F EZ W/145 PG.038 INP
• 20613994939818: CATH 6A0100 SS 5PK6F EZ W/.038 INP STRPG
• 20613994939726: CATH 6A0073 SS 5PK6F EZ W/3DRC XT.035INP
• 20613994939702: CATH 6A0068 SS 5PK6F EZ W/155 PG.35 INP
• 20613994939696: CATH 6A0067 SS 5PK6F EZ W/145 PG .035INP
• 20613994939689: CATH 6A0066 SS 5PK6F EZ W/STR PG .035INP
• 20613994938569: CATHETER 388420 PF 5PK 6F ST EZ-PAK
• 20613994938484: CATHETER 388410 PF 5PK 6F EZ PK
• 20613994938422: CATHETER 384902 PF 5PK KIT 7F ST EZ-PAK
• 20613994938408: CATH 358484 PF 5PK 6F BTO EZ W/.035 WIRE
• 20613994938132: CATHETER 350010 PF 5PK KIT 7F ST EZ-PAK
• 20613994936220: CATH 5A0093 SS 5PK5F EZ W/145 PG .038INP
• 20613994936213: CATH 5A0092 SS 5PK 5F EZ W/STR PG.038INP
• 20613994936206: CATH 5A0073 SS 5PK5F EZW/STR PG 3DRC INP
• 20613994936183: CATH 5A0067 SS 5PK 5F EZ W/155PTAIL INP
• 20613994936176: CATH 5A0066 SS 5PK 5F EZ W/145PTAIL INP
• 20613994936169: CATH 5A0065 SS 5PK 5F EZ W/INP STR PGT