SAM Medical IO705W

GUDID 00850068519057

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.

ZIEN MEDICAL TECHNOLOGIES, INC.

Intraosseous infusion kit

• Primary Device ID: 00850068519057
• NIH Device Record Key: 9ba35327-f29a-4a60-8425-7799d5bf65bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAM Medical
• Version Model Number: IO705W
• Catalog Number: IO705W
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068519040 [Primary]
GS1	00850068519057 [Package]; Contains: 00850068519040; Package: 1Pk Carton [1 Units]; In Commercial Distribution
GS1	00850068519064 [Package]; Contains: 00850068519040; Package: 5Pk Carton [5 Units]; In Commercial Distribution
GS1	10850068519054 [Package]; Package: 1Pk Shipper [30 Units]; In Commercial Distribution
GS1	10850068519061 [Package]; Contains: 00850068519064; Package: 5Pk Shipper [6 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-08
• Device Publish Date: 2024-10-31

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.