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SAM IO Intraosseous Access System

FDA UDI

Class II (US FDA UDI)

by SAM Medical Products

Identity

Trade Name
SAM IO Intraosseous Access System FDA UDI
Generic Name
Intraosseous-access handpiece, infusion, manual FDA UDI
Device Name
SAM IO - Driver - 1 Pack FDA UDI
Model / Reference
IO700-EN FDA UDI
Description
SAM IO - Driver - 1 Pack FDA UDI

Identifiers

Primary DI / UDI-DI
00822045000247 FDA UDI
510(k) Number
K191488 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Intraosseous-access handpiece, infusion, manual 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-access handpiece, infusion, manual

SAM IO Intraosseous Access System by SAM Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K191488 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SAM Medical Products

Sources (1)

  • FDA UDI 633d611e-6bd2-4494-ba0b-48f3aca8d389 35 fields · synced Jun 8, 2026