Identity
- Trade Name
- SAM IO Intraosseous Access System FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- SAM IO - Adaptor - 1 Pack FDA UDI
- Model / Reference
- IO742-EN FDA UDI
- Description
- SAM IO - Adaptor - 1 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045000322 FDA UDI
- 510(k) Number
- K191488 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Intraosseous infusion kit
SAM IO Intraosseous Access System by SAM Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191488 also covers:
- FORWARD IO INFUSION KIT — INTEGRATED MEDCRAFT LLC
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
- SAM IO Intraosseous Access System — SAM Medical Products
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SAM Medical Products
Sources (1)
- FDA UDI ac023dec-a875-4eb6-a17c-ff25a328a04e 35 fields · synced Jun 8, 2026