FDA.reportPublic FDA data

SAM Medical

Primary DI
00850068519378
Brand
SAM Medical
Company
Zien Medical Technologies, LLC
Model
IO846-1P
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. SAM IO Adaptor2
Published
2026-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850068519375PackageGS130In Commercial Distribution
00850068519378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006851937510850068519375
00850068519378008500685193788500685193780850068519378

GMDN Terms#

Term, Definition table
TermDefinition
Intraosseous infusion kitA 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.

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068519361SAM MedicalIO845-1P2026-09-03
00850068519385SAM MedicalIO847-1P2026-09-03
10853624005008PenBlade Safety Scalpel#10 BladePB-M-102020-09-21
10853624005015PenBlade Safety Scalpel#11P BladePB-M-11P2020-09-21
10853624005022PenBlade Safety Scalpel#15 BladePB-M-152020-09-21
B0902P0130B0Knight Microcatheter2P0-130-B2P0-130-B2024-04-30
B0902P0130S0Knight Microcatheter2P0-130-S2P0-130-S2024-04-30
B0905XGW0SPINR5X-GW5X-GW2022-07-21
B090A110600Control 11F Mechanical Thrombectomy System, 60cmA11-060A11-0602022-06-29
B090A110900Control 11F Mechanical Thrombectomy SystemA11-090A11-0902022-06-29
B090A50550Aspire Max 5 Aspiration Catheter 55cmA5-055A5-0552017-08-17
B090A51350Control 5F Mechanical Thrombectomy System 135cmA5-135A5-1352017-08-17
B090A61350Control 6F Mechanical Thrombectomy System 135cmA6-135A6-1352017-08-17
B090A70900Control 7F Mechanical Thrombectomy SystemA7-090A7-0902022-06-29
B090A90600Control 9F Mechanical Thrombectomy System, 60cmA9-060A9-0602022-06-29
B090A90900Control 9F Mechanical Thrombectomy System, 90cmA9-090A9-0902022-06-29
B090ARXLP60Control RX-LP Mechanical Thrombectomy System, 136cmARX-LP6ARX-LP62017-08-17
B090ASP10010Control RX-LP Mechanical Thrombectomy SystemASP-1001ASP-10012023-04-26
B090ASP10130Control 7F Mechanical Thrombectomy SystemASP-1013ASP-10132023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemASP-1021ASP-10212023-05-03

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Primary DI, Brand, Company table
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10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850068519361SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26