SAM IO Intraosseous Access System

GUDID 30822045000293

SAM IO - 45mm Needle Assembly - 5 Pack

SAM Medical Products

Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit

• Primary Device ID: 30822045000293
• NIH Device Record Key: a0d423c8-304b-4d9c-849c-014b0593cfa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM IO Intraosseous Access System
• Version Model Number: IO707-5P-EN
• Company DUNS: 131084188
• Company Name: SAM Medical Products
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com
• Phone: 5036395474
• Email: quality@sammedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10822045000299 [Primary]
GS1	30822045000293 [Package]; Contains: 10822045000299; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191488

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-05
• Device Publish Date: 2020-02-26

On-Brand Devices [SAM IO Intraosseous Access System]

• 20822045000289: SAM IO - 25mm Needle Assembly - 5 Pack
• 30822045000293: SAM IO - 45mm Needle Assembly - 5 Pack
• 20822045000272: SAM IO - 15mm Needle Assembly - 5 Pack
• 10822045000329: SAM IO - Adaptor - 1 Pack
• 20822045000296: SAM IO - 45mm Needle Assembly - 1 Pack
• 10822045000282: SAM IO - 25mm Needle Assembly - 1 Pack
• 00822045000278: SAM IO - 15 mm Needle Assembly - 1 Pack
• 10822045000244: SAM IO - Driver - 1 Pack
• 30822045000309: SAM IO Stabilizer - 5 Pack
• 20822045000302: SAM IO Stabilizer - 1 Pack