Identity
- Trade Name
- Protego Air Water Bottle Tubing FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Model / Reference
- 202002US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106955930 FDA UDI
- 510(k) Number
- K231602 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic insufflation tubing set, single-use
Protego Air Water Bottle Tubing by GA Health Company Limited — 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
K231602 also covers:
- Protego Air Water Bottle Tubing — GA Health Company Limited
- Protego Air Water Bottle Tubing with CO2 Extend — GA Health Company Limited
- Protego Air Water Bottle Tubing with CO2 Extend — GA Health Company Limited
- Protego Air Water Connector — GA Health Company Limited
- Protego Air Water Connector — GA Health Company Limited
- Protego Hybrid Tubing — GA Health Company Limited
- Protego Hybrid Tubing — GA Health Company Limited
- Protego Hybrid Tubing with CO2 Extend — GA Health Company Limited
- Protego Hybrid Tubing with CO2 Extend — GA Health Company Limited
- Fuji 700 4-piece Valve Kit — US Endoscopy
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
- GA Health Company Limited
Sources (1)
- FDA UDI ea4ddb21-ea3c-4011-8d17-7c901d5fc7a8 33 fields · synced May 30, 2026