Identity
- Trade Name
- Hydra FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, reusable FDA UDI
- Device Name
- Water Bottle Cap System FDA UDI
- Model / Reference
- SCT-609 FDA UDI
- Description
- Water Bottle Cap System FDA UDI
Identifiers
- Catalog Number
- SCT-609 FDA UDI
- Primary DI / UDI-DI
- 00840253111609 FDA UDI
- FDA Product Code
- FEQ FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, reusable 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, reusable
Hydra by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic insufflation tubing set, reusable.
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- CO2 Source Tubing Adapter (Non-Sterile) — GA Health Company Limited · Class I
- ENDO SMARTCAP — MEDIVATORS INC. · Class II
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
- Boston Scientific
Sources (1)
- FDA UDI b9b3f658-c1d3-4d95-9d0d-b02a0f9cafd9 34 fields · synced Jun 1, 2026