Identity
- Trade Name
- andorate® CO2 Source Tubing Adapter FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, reusable FDA UDI
- Model / Reference
- GAR108 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106955862 FDA UDI
- FDA Product Code
- NKC FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
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, reusable
andorate® CO2 Source Tubing Adapter by GA Health Company Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic insufflation tubing set, reusable.
- Insufflation tube — Guangdong Optomedic Technologies, Inc. · Class II
- MEDICAL GAS PIPELINE ADAPTOR (DISS) FOR UHI-3 — Olympus Medical Systems Corporation · Class II
- CO2 Source Tubing Adapter Olympus UCR — Micro-tech Usa · Class I
- CYLINDER HOSE — Olympus Medical Systems Corporation · Class II
- LOW FLOW GAS TUBE — Olympus Medical Systems Corporation · Class II
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
- Hydra — Boston Scientific · Class II
- EXTRA LOW FLOW GAS TUBE — Olympus Medical Systems Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GA Health Company Limited
Sources (2)
- FDA UDI 3b3f6dbe-3ed9-47e1-ac54-3d1cb3b71909 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026