Identity
- Trade Name
- Silicone Thoracic Drain, S Type FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Model / Reference
- 2018-0022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14710961936029 FDA UDI
- FDA Product Code
- GBS FDA UDI
- GMDN Term
- Pleural catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
No
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
Category: Pleural catheter
Silicone Thoracic Drain, S Type by Fortune Medical Instrument Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pleural catheter.
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED · Class I
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED · Class I
- Wayne — COOK INCORPORATED · Class II
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED · Class I
- Axiom® PVC — AXIOM MEDICAL, INCORPORATED · Class I
- PLEUR-EVAC — TELEFLEX INCORPORATED · Class I
- Rocket — Rocket Medical Plc · Class I
- Axiom® — AXIOM MEDICAL, INCORPORATED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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
- Fortune Medical Instrument Corp.
Sources (2)
- FDA UDI 3dea0b06-0fa5-47c1-95e9-d26e51616189 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026