Identity
- Trade Name
- WoundPro Collection Canister FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- WoundPro 300cc Collection Canister with 5 foot tubing, Case of 16 FDA UDI
- Model / Reference
- 8463540 0222 FDA UDI
- Description
- WoundPro 300cc Collection Canister with 5 foot tubing, Case of 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851978007013 FDA UDI
- 510(k) Number
- K150960 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system canister 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system canister
WoundPro Collection Canister by Pensar Medical, 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 canister.
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Cleared under the same submission
K150960 also covers:
- 300cc Advanced Canister w/5' Tubing — Pensar Medical, LLC
- 300cc Advanced Canister w/8' Tubing — Pensar Medical, LLC
- 800cc Advanced Canister w/5' Tubing — Pensar Medical, LLC
- 800cc Advanced Series Canister w/8' Tubing — Pensar Medical, LLC
- 800cc Basic Canister w/8' Tubing — Pensar Medical, LLC
- Advanced Series Combo Pack, Large — Pensar Medical, LLC
- Advanced Series Combo Pack, Medium — Pensar Medical, LLC
- Advanced Series Combo Pack, Small — Pensar Medical, LLC
- Advanced Series Hydrophobic Dressing Kit, Large — Pensar Medical, LLC
- Advanced Series Hydrophobic Dressing Kit, Medium — Pensar Medical, LLC
- Advanced Series Hydrophobic Dressing Kit, Small — Pensar Medical, LLC
- Advanced Series StingRay Suction Bell — Pensar Medical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pensar Medical, LLC
Sources (1)
- FDA UDI f00e9f54-cc3c-4b5b-990a-89c39cd9820e 34 fields · synced May 31, 2026