Identity
- Trade Name
- PLEUR-EVAC FDA UDI
- Generic Name
- Thoracic suction collection container FDA UDI
- Device Name
- PLEUR-EVAC DRY/WET DUAL COLLECTION LATEX FREE FDA UDI
- Model / Reference
- IPN028443 FDA UDI
- Description
- PLEUR-EVAC DRY/WET DUAL COLLECTION LATEX FREE FDA UDI
Identifiers
- Catalog Number
- A-6002-08LF FDA UDI
- Primary DI / UDI-DI
- 34026704631248 FDA UDI
- 510(k) Number
- K905768 FDA UDI
- FDA Product Code
- KDQ FDA UDI
- GMDN Term
- Thoracic suction collection container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Dimensions & Sizes
- Size
- Total Volume — 1900 Milliliter FDA UDILength — 16.5 Inch FDA UDIDepth — 2.5 Inch FDA UDIWidth — 12.75 Inch FDA UDI
Category: Thoracic suction collection container
Pleur-Evac by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic suction collection container.
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- GBUK GROUP LIMITED — Pacific Hospital Supply Company Limited · Class II
- EXPRESS — Atrium Medical Corp. · Class II
- Pleura Med — Solomed, S.A. de C.V. · Class II
- Vide — Alleva Medical, Ltd. · Class II
- Vide — Alleva Medical, Ltd. · Class II
- Vide — Alleva Medical, Ltd. · Class II
Cleared under the same submission
K905768 also covers:
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR EVAC — TELEFLEX INCORPORATED
- PLEUR-EVAC — TELEFLEX INCORPORATED
- PLEUR-EVAC — TELEFLEX INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI ffa2dce5-7a78-493a-8c63-92f91097fe07 37 fields · synced May 30, 2026