SAM Medical

GUDID 10850068519269

The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. SAM IO Adaptor2

ZIEN MEDICAL TECHNOLOGIES, INC.

Intraosseous infusion kit

• Primary Device ID: 10850068519269
• NIH Device Record Key: c5bf3b44-adad-4365-82a9-f85be7e81cb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM Medical
• Version Model Number: IO845W-1P
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068519262 [Primary]
GS1	10850068519269 [Package]; Contains: 00850068519262; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240915

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [SAM Medical ]

• 00850068519118: The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
• 00850068519088: The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
• 00850068519057: The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal
• 00860412001572: Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage.
• 10850068519221: SAM IO - Adaptor
• 10850068519030: SAM IO Driver
• 00850068519026: SAM IO Stabilizer
• 10850068519269: The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
• 10850068519252: The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
• 10850068519245: The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis
• 10850068519238: SAM IO - Adaptor2