Identity
- Trade Name
- SMITH & NEPHEW 400 FDA UDI
- Generic Name
- Insufflation gas conditioning system control unit FDA UDI
- Device Name
- S&N 400 INSUFFLATOR KIT US FDA UDI
- Model / Reference
- 7209933 FDA UDI
- Description
- S&N 400 INSUFFLATOR KIT US FDA UDI
Identifiers
- Catalog Number
- 7209933 FDA UDI
- Primary DI / UDI-DI
- 00885554012286 FDA UDI
- 510(k) Number
- K022052 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Insufflation gas conditioning system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 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
Yes
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
No
FDA UDI
Category: Insufflation gas conditioning system control unit
Smith & Nephew 400 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022052 also covers:
- CONMED — Conmed Corporation
- CONMED — Conmed Corporation
- Adapter for Hoses — Northgate Technologies Inc.
- CO2 Hose and DIN — Northgate Technologies Inc.
- CO2 Hose and DISS — Northgate Technologies Inc.
- CO2 Hose and Yoke — Northgate Technologies Inc.
- CO2 Hose and Yoke Shuttle Valve System — Northgate Technologies Inc.
- Connector, Barbed High Flow, Insufflation — Northgate Technologies Inc.
- SMITH & NEPHEW 400 — Smith & Nephew, Inc.
- SMITH & NEPHEW 400 — Smith & Nephew, Inc.
- SMITH & NEPHEW 400 — Smith & Nephew, Inc.
- SMITH & NEPHEW 400 — Smith & Nephew, Inc.
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, Inc.
Sources (1)
- FDA UDI e272261f-03e3-4d65-9394-ed2f0e011dc3 36 fields · synced Jun 8, 2026