Identity
- Trade Name
- SAM IO ® Adaptor EUDAMEDSAM Medical FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- SAM IO Adaptor EUDAMEDSAM IO - Adaptor FDA UDI
- Model / Reference
- IO742 EUDAMEDFDA UDI
- Description
- SAM IO - Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068519224 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850068519IO742TN EUDAMED
- 510(k) Number
- K240915 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A018004 NEEDLE CONNECTORS AND ADAPTERS EUDAMED
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SAM IO ® Adaptor by ZIEN Medical Technologies, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850068519IO742TN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
- EUDAMED SRN
- US-MF-000004717
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED e6c00452-3f55-44bc-9bbb-f686dfe7bb53 61 fields · synced Oct 6, 2026
- FDA UDI a9bc9455-dcfb-4fee-9bad-eef3e05bafb0 34 fields · synced May 29, 2026