SAM IO Intraosseous Access System

Basic Information

• Brand Name: SAM IO Intraosseous Access System
• Primary DI: 10822045000305
• Version / Model: IO740-5P-EN
• Company Name: SAM Medical Products
• Labeler DUNS: 131084188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-28
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: e346251f-c052-4dcc-9eaa-fb05b2004629

Device Description

SAM IO Stabilizer - 5 Pack

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: Yes
• 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
KMK	Device, Intravascular Catheter Securement	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64501	Catheter/tubing connection protector	A small, rigid box/clip/pouch intended to be fitted over/around the connection juncture between a catheter and a tube, or between tubing (i.e., where there is a connector, stopcock, or valve/manifold), to create a physical barrier for protection against accidental handling and contamination. It may include a foam containing a disinfectant or intended to be soaked in disinfectant prior to use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30822045000309	GS1	Case	6	In Commercial Distribution
Primary	10822045000305	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]