SAM IO Intraosseous Access System

Basic Information

• Brand Name: SAM IO Intraosseous Access System
• Primary DI: 00822045000308
• Version / Model: IO740-1P-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: 1862881d-2953-4618-947b-ee303d5c15a4

Device Description

SAM IO Stabilizer - 1 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	20822045000302	GS1	Case	30	In Commercial Distribution
Primary	00822045000308	GS1

Customer Contacts

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