Identity
- Trade Name
- Invia Drain Adapter FDA UDI
- Generic Name
- Negative-pressure wound therapy tubing set FDA UDI
- Model / Reference
- 087.0024 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367041195 FDA UDI
- 510(k) Number
- K142626 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy tubing set
Invia Drain Adapter by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142626 also covers:
- Docking Station — Medela LLC
- Holder with standard rail — Medela LLC
- Invia Liberty — Medela LLC
- Invia Liberty — Medela LLC
- Invia Liberty Carrying Case — Medela LLC
- Invia Liberty Tubing with quick connector — Medela LLC
- Invia Liberty Y-Connector with quick connector — Medela LLC
- Invia Liberty canister 0.3l — Medela LLC
- Invia Liberty canister 0.8l — Medela LLC
- Standard rail universal holder — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI 1b861cad-9a22-4c36-8d15-4fd181bc3007 34 fields · synced Jun 1, 2026