Identity
- Trade Name
- Ch24 round silicone catheter FDA UDI
- Generic Name
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
- Model / Reference
- 000 FDA UDI
Identifiers
- Catalog Number
- R9900099 FDA UDI
- Primary DI / UDI-DI
- M640R99000990001 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 600 Millimeter FDA UDICatheter Gauge — 24 French FDA UDI
Ch24 round silicone catheter by Rand Spa — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rand Spa
Sources (2)
- FDA UDI 064729b2-9ac3-4a96-8546-59c4e0d2432b 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026