Stradis Medical, LLC.

GUDID M7525250385

5FR Micro-Introducer Kit

STRADIS MEDICAL, LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: M7525250385
• NIH Device Record Key: 5fd3eb8a-5122-4da2-8415-518b96924e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stradis Medical, LLC.
• Version Model Number: 525-038
• Company DUNS: 174262477
• Company Name: STRADIS MEDICAL, LLC
• 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: true
• 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: 1-800-424-8520
• Email: cs@stradishealthcare.com
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM
• Phone: 770-962-2425
• Email: SERVICE@STRADISHEALTHCARE.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7525250380 [Primary]
HIBCC	M7525250385 [Package]; Contains: M7525250380; Package: outer carton [10 Units]; In Commercial Distribution

FDA Product Code

• OFL: Percutaneous Sheath Introducer Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-08-24

On-Brand Devices [Stradis Medical, LLC.]

• M752MSACCESS0: PRP Accessories Kit
• M752HMACCESS5: PRP Accessories Kit
• M752GBRM14000: PRP Accessories Kit
• M752WC1455: Wound Pak
• M752991017205: Mosquito Forceps
• M752WC1305: Insect Sting Pak
• M752UPC1025: Bio-Quik Spill Pak
• M752IM12605: Central Line Kit, Stat
• M752525038R10: 5FR Micro-Introducer Kit
• M7525250385: 5FR Micro-Introducer Kit
• M752750HOSE1: Compression Hose Kit
• M75268220005: Donners and Gloves
• M752TMBRF2550: Hypodermoclysis Kit
• M752SUBMKSQA0: Hypodermoclysis Prep Kit
• M752RSIV16186N5: IV Start Kit
• M752O11145: IV Start Kit
• M752MKSQ011276B0: Hypodermoclysis Kit
• M752MKSQ011276A5: Hypodermoclysis Kit
• M752MKSQ011249B5: Hypodermoclysis Kit
• M752MKSQ011249A5: Hypodermoclysis Kit
• M752MKSQ011246A5: Hypodermoclysis Kit
• M752MAG30005: Neonatal PICC Tray
• M752IVECONO15: IV Start ECONO1 Kit W/CHG
• M752IV7650: IV Start Kit
• M752IV7600: IV START KIT
• M752IV180C5: IV Start Kit
• M752IV175C0: IV Start Kit W/CHLORHEXIDINE
• M752IV1750: IV Start Kit
• M752IV170655: IV Start Kit
• M752IV162955: IV Start Kit
• M752ISK95125: IV Start Kit
• M752ISIVMEC5: IV Start Kit
• M752ISIV744CP15: IV Start Kit
• M752ISIV6235: IV Start Kit
• M752IMSEN102A5: IV Start Kit
• M752IMSEN101A5: PICC/ MIDLINE DRESSING KIT
• M752IM12515: Central Line Tray
• M752IM12355: Central Line Tray
• M752HCT9925CP0: Central Line Dressing Change Kit
• M752HCT900ABP0: Arterial line Dressing Change Kit - Small Biopatch
• M752HCT8874VA0: Port Access Tray
• M752HCT8136CP0: Central Line Dressing Kit
• M752HCT8025: IV Start Kit
• M752HCT801CP0: IV Start Kit
• M752HCT71820: Central Line Dressing Kit
• M752HCT6625TC5: TUFTS Central line Dressing Change Kit
• M752HCT6057CP0: Central Line Discontinuation Kit
• M752HCT2121CP5: IV Start Kit
• M752HCT200BP0: Dressing Change Kit - Large Biopatch
• M752DC850A0: PICC/Midline Cath Tray