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I/A Tubing
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ICM-000-0295Ref ICM-000-0448
Identity
- Trade Name
- I/A Tubing EUDAMEDFDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- Smoke Accessories Non-Sterile EUDAMED
- Model / Reference
- ICM-000-0448 EUDAMEDFDA UDIICM-000-0295 EUDAMEDFDA UDI2190 FDA UDI
Identifiers
- Catalog Number
- ICM-000-0416 FDA UDI
- Primary DI / UDI-DI
- 00817688021964 EUDAMEDFDA UDI00817688021308 EUDAMEDFDA UDI00817688021322 FDA UDI
- Basic UDI-DI
- 081768802SmokeAccessNS6J EUDAMED
- Unit of Use DI
- 00817688021346 EUDAMED
- FDA Product Code
- FYD FDA UDI
- EMDN Code
- Z12019085 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - CONSUMABLES EUDAMED
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIFDA 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
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Ethylene Oxide FDA UDI
I/A Tubing by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- I.C. Medical, Inc.
Sources (5)
- FDA UDI 9884baa3-cb10-4a8f-af3f-fc8acdfe6499 34 fields · synced Oct 5, 2026
- FDA UDI 48860fcb-5d80-486d-86df-34d84806d819 32 fields · synced May 29, 2026
- FDA UDI 50f655ae-f225-4d95-b9d6-76b3f9860bc1 32 fields · synced May 30, 2026
- EUDAMED 388db788-f8b4-43d4-b93e-812071e3bfb8 61 fields · synced Jul 23, 2026
- EUDAMED ad7a3e69-0088-4132-8e24-c7c955345dee 61 fields · synced Aug 4, 2026