Identity
- Trade Name
- Invia Motion 15 Days FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, reusable FDA UDI
- Device Name
- Negative Pressure Wound Therapy System / 087.4012 FDA UDI
- Model / Reference
- 200.8589 FDA UDI
- Description
- Negative Pressure Wound Therapy System / 087.4012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367053167 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Negative-pressure wound therapy system, electric, reusable
Invia Motion 15 Days by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161128 also covers:
K172145 also covers:
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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 f2618cde-7825-4588-8a1a-f86f31ca5d3f 35 fields · synced Jun 8, 2026