Device
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 th...
Manufacturer
ZIEN MEDICAL TECHNOLOGIES, INC.
ZIEN MEDICAL TECHNOLOGIES, INC.
Model: IO806
Catalog: IO806
DI: 00850068519309
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
15569902-af15-4382-a7c3-7df7d2019e6b
Distribution Status:
In Commercial Distribution
DUNS Number:
017535668
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
1Pk Carton
Item #1 - Device ID:
00850068519316
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850068519309
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850068519309
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
1Pk Shipper
Item #3 - Device ID:
10850068519313
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
30
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00850068519316
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Pkg Type:
5Pk Carton
Item #4 - Device ID:
00850068519323
Item #4 - Pkg Status:
In Commercial Distribution
Item #4 - Pkg Quantity:
5
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
00850068519309
Item #4 - Device ID Issuing Agency:
GS1
Item #5 - Pkg Type:
5Pk Carton
Item #5 - Device ID:
10850068519320
Item #5 - Pkg Status:
In Commercial Distribution
Item #5 - Pkg Quantity:
6
Item #5 - Device ID Type:
Package
Item #5 - Contains DINumber:
00850068519323
Item #5 - Device ID Issuing Agency:
GS1
GMDN
Code: 18009
Name: Intraosseous infusion kit
Definition:
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.
FDA Product Codes
FMI
Needle, Hypodermic, Single Lumen