Identity
- Trade Name
- Invia Foam Dressing Kit FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Device Name
- Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs FDA UDI
- Model / Reference
- 200.8905 FDA UDI
- Description
- Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367050005 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system dressing 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
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
Yes
FDA UDI
Category: Negative-pressure wound therapy system dressing set
Invia Foam Dressing Kit by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system dressing set.
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Cleared under the same submission
K170088 also covers:
K172145 also covers:
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- Invia Motion 15 Days — Medela LLC
- Invia Motion 15 Days Kit 10 x 10 cm — 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 56860bc1-832a-429e-85d0-8bdb3b90e75d 34 fields · synced Jun 8, 2026