Identity
- Trade Name
- SAM IO ® Stabilizer EUDAMEDSAM Medical FDA UDI
- Generic Name
- Catheter/tubing connection protector FDA UDI
- Device Name
- SAM IO Stabilizer EUDAMEDFDA UDI
- Model / Reference
- IO740 EUDAMEDFDA UDI
- Description
- SAM IO Stabilizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068519002 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850068519IO740TJ EUDAMED
- FDA Product Code
- KMK FDA UDI
- EMDN Code
- C010599 INTRAVASCULAR PROTECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Catheter/tubing connection protector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5210 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SAM IO ® Stabilizer 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 | 0850068519IO740TJ | 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 7155f926-e3c6-4af7-b55d-b11d3d1a320a 61 fields · synced Jun 18, 2026
- FDA UDI 34113e2c-b170-489c-a124-cb12383a3550 33 fields · synced May 29, 2026