Identity
- Trade Name
- CODMAN HAKIM SIPHONGUARD HOLTER FDA UDI
- Generic Name
- Ventriculo-peritoneal/atrial shunt FDA UDI
- Device Name
- CODMAN HAKIM Programmable Valve In-Line Valve SIPHONGUARD Device, .060 Inch Platform and Unitized Distal Catheter Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) programmable in steps of 10mm H2O (98 Pa) Includes: Ventricular Catheter 14cm, Stylet, Right Angle Adaptor, Straight Connector, HOLTER Type B Connector, Priming Adaptor and Information Manual FDA UDI
- Model / Reference
- 82-3854 FDA UDI
- Description
- CODMAN HAKIM Programmable Valve In-Line Valve SIPHONGUARD Device, .060 Inch Platform and Unitized Distal Catheter Operating Pressure: 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) programmable in steps of 10mm H2O (98 Pa) Includes: Ventricular Catheter 14cm, Stylet, Right Angle Adaptor, Straight Connector, HOLTER Type B Connector, Priming Adaptor and Information Manual FDA UDI
Identifiers
- Catalog Number
- 823854 FDA UDI
- Primary DI / UDI-DI
- 10886704041900 FDA UDI
- 510(k) Number
- K053350 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventriculo-peritoneal/atrial shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Codman Hakim Siphonguard Holter by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI eabfd9f9-3f2a-491d-849d-1f6c4fb1571f 37 fields · synced Jun 8, 2026