FDA.reportPublic FDA data

SAM Medical

Primary DI
10850068519245
Brand
SAM Medical
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
IO847W-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
2025-12-09
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240915000ZIEN IO Intraosseous Access SystemZien Medical Technologies, Inc.2024-07-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850068519245PackageGS130In Commercial Distribution
00850068519248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006851924510850068519245
00850068519248008500685192488500685192480850068519248

Sterilization Methods#

Method table
Method

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
B090MT2021MorTanMT202 2026-02-10
B090XC2201451XO ConstrainXC2.20-1452026-02-03
10850068519238SAM Medical IO8422025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24
10850049994863Syntervention 4008-2032025-09-26
10850049994870Syntervention 4008-3032025-09-26
10850049994887Syntervention 4008-4032025-09-26
10850049994894Syntervention 4008-2052025-09-26
10850049994900Syntervention 4008-3052025-09-26
10850049994917Syntervention 4008-4052025-09-26
10850049994924Syntervention 4008-2072025-09-26
10850049994931Syntervention 4008-3072025-09-26
10850049994948Syntervention 4008-4072025-09-26
10850049994955Syntervention 4008-2092025-09-26
10850049994962Syntervention 4008-3092025-09-26
10850049994979Syntervention4007-4092025-09-26
10858303003009Syntervention 50012025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16972857299481PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299498PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299504PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299511PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299528PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299467PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-03
00613703823106EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823304EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823908EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853103EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853202EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853301EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853400EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853509EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853608EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853707EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853806EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853905EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00840216124264LiteTouchAsp Global, LLCFMI2026-11-02
00840216123793LiteTouchAsp Global, LLCFMI2026-10-30
00840216123823LiteTouchAsp Global, LLCFMI2026-10-30
00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09