Identity
- Trade Name
- PLEUR-EVAC FDA UDI
- Generic Name
- Pleural drainage valve FDA UDI
- Device Name
- PLEUR EVAC PATIENT TUBING PLUG FDA UDI
- Model / Reference
- IPN916510 FDA UDI
- Description
- PLEUR EVAC PATIENT TUBING PLUG FDA UDI
Identifiers
- Catalog Number
- PE105 FDA UDI
- Primary DI / UDI-DI
- 14026704734693 FDA UDI
- FDA Product Code
- GCD FDA UDI
- GMDN Term
- Pleural drainage valve 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 2 Inch FDA UDI
Category: Pleural drainage valve
Pleur-Evac by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Synchronis — SYNCHRONIS MEDICAL LLC · Class II
- CMC MED SOLUTIONS — CMC Manufacturing Limited Liability Company · Class II
- CMC MED SOLUTIONS — CMC Manufacturing Limited Liability Company · 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
- Teleflex Incorporated
Sources (1)
- FDA UDI a5708588-823b-4e68-9d4d-c9c7b76fd66a 36 fields · synced Jun 8, 2026