Identity
- Trade Name
- Aqueduct SED FDA UDI
- Generic Name
- Cerebrospinal fluid pressure regulation system fluid-collection set FDA UDI
- Device Name
- The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF. FDA UDI
- Model / Reference
- ACC-BAG-100 FDA UDI
- Description
- The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ACCBAG000 FDA UDI
- 510(k) Number
- K161605 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Cerebrospinal fluid pressure regulation system fluid-collection set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Cerebrospinal fluid pressure regulation system fluid-collection set
Aqueduct SED by Aqueduct Critical Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K161605 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Aqueduct Critical Care, Inc.
Sources (1)
- FDA UDI f1526e8a-46b3-470e-b72b-24aa004d2737 34 fields · synced Jun 8, 2026