Identity
- Trade Name
- Pico 14 FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, single-use FDA UDI
- Device Name
- PICO 14 25cm x 25cm US CTN1 FDA UDI
- Model / Reference
- 66022049 FDA UDI
- Description
- PICO 14 25cm x 25cm US CTN1 FDA UDI
Identifiers
- Catalog Number
- 66022049 FDA UDI
- Primary DI / UDI-DI
- 05000223495459 FDA UDI
- 510(k) Number
- K191760 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, single-use 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Negative-pressure wound therapy system, electric, single-use
Pico 14 by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system, electric, single-use.
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- MicroDoc NPWT Control Unit — Pensar Medical, LLC · Class II
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- Avance® Solo — Mölnlycke Health Care AB · Class II
- PREVENA™ PEEL & PLACE™ — KCI USA, INC. · Class II
- UNO 15 Therapy Kit 10x10 — GENADYNE BIOTECHNOLOGIES, INC. · Class II
- MicroDoc NPWT System — Pensar Medical, LLC · Class II
- Avance® Solo — Mölnlycke Health Care AB · Class II
Cleared under the same submission
K191760 also covers:
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
- Pico 14 — Smith & Nephew Medical, Ltd.
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
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 2eb4f47a-b647-4d1b-9283-0b9a4c4ff4d2 35 fields · synced May 30, 2026