Identity
- Trade Name
- Connector, Barbed High Flow, Insufflation FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Model / Reference
- 8055 FDA UDI
Identifiers
- Catalog Number
- 72-00147-0 FDA UDI
- Primary DI / UDI-DI
- 00817183020653 FDA UDI
- 510(k) Number
- K022052 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, single-use 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
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: Endoscopic insufflation tubing set, single-use
Connector, Barbed High Flow, Insufflation by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic insufflation tubing set, single-use.
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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.
- SMITH & NEPHEW 400 — Smith & Nephew, 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
- Northgate Technologies Inc.
Sources (1)
- FDA UDI fd84b084-fb6f-40b1-b6c3-72111451693f 34 fields · synced May 30, 2026