Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
- Device Name
- SCHMID Vessel Irrigation Cannula, 6", (150 mm), diam. 6 mm, malleable, luer lock, non-sterile, reusable FDA UDI
- Model / Reference
- FB156R FDA UDI
- Description
- SCHMID Vessel Irrigation Cannula, 6", (150 mm), diam. 6 mm, malleable, luer lock, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FB156R FDA UDI
- Primary DI / UDI-DI
- 04038653419487 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Aesculap by Aesculap, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return.
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- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- PureFlex Arterial Cannulae — SORIN GROUP ITALIA SRL · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI c096d586-dd08-4747-b165-9abf9156f251 35 fields · synced Jun 8, 2026