SAM IO Intraosseous Access System

GUDID 10822045000244

SAM IO - Driver - 1 Pack

SAM Medical Products

Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual Intraosseous-access handpiece, infusion, manual

• Primary Device ID: 10822045000244
• NIH Device Record Key: 633d611e-6bd2-4494-ba0b-48f3aca8d389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM IO Intraosseous Access System
• Version Model Number: IO700-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: false
• 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: 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	00822045000247 [Primary]
GS1	10822045000244 [Package]; Contains: 00822045000247; Package: Case [10 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: false

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