SAM Medical

Basic Information

• Brand Name: SAM Medical
• Primary DI: 00850068519040
• Version / Model: IO705W
• Catalog Number: IO705W
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 017535668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-31
• Public Version: 1
• Public Version Date: 2024-11-08
• Public Version Status: New
• Public Device Record Key: 9ba35327-f29a-4a60-8425-7799d5bf65bc

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18009	Intraosseous infusion kit	A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850068519057	GS1	1Pk Carton	1	In Commercial Distribution
Primary	00850068519040	GS1
Package	10850068519054	GS1	1Pk Shipper	30	In Commercial Distribution
Package	00850068519064	GS1	5Pk Carton	5	In Commercial Distribution
Package	10850068519061	GS1	5Pk Shipper	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K240915	000