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SAM IO ® Needle - 45mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref IO707W

by ZIEN Medical Technologies, LLC

Identity

Trade Name
SAM IO ® Needle - 45mm EUDAMED
SAM Medical FDA UDI
Generic Name
Intraosseous infusion kit FDA UDI
Device Name
SAM IO Needle EUDAMED
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. FDA UDI
Model / Reference
IO707W EUDAMEDFDA UDI
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. FDA UDI

Identifiers

Catalog Number
IO707W FDA UDI
Primary DI / UDI-DI
00850068519101 EUDAMEDFDA UDI
Basic UDI-DI
0850068519IO70XVL EUDAMED
510(k) Number
K240915 FDA UDI
FDA Product Code
FMI FDA UDI
EMDN Code
A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
GMDN Term
Intraosseous infusion kit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

SAM IO ® Needle - 45mm by ZIEN Medical Technologies, LLC — Class IIa — 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

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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 fbfbdbc0-f612-4a9b-b7c8-092e103ee833 61 fields · synced Jun 18, 2026
  • FDA UDI 805e7e6a-0d54-49ee-8194-ec745e7b6df3 35 fields · synced May 30, 2026