Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Medical air low pressure hose FDA UDI
- Device Name
- This product is the tube kit used in combination with the compatible balloon controller in medical facilities . Do not use this product for any other purpose The product consists of a tube for connection to the endoscope and over-tube and balloon controller, and a filter. This product is supplied non-sterile. Also, The filter is a single patient use item. Prepare a new filter before use. FDA UDI
- Model / Reference
- TY-500D FDA UDI
- Description
- This product is the tube kit used in combination with the compatible balloon controller in medical facilities . Do not use this product for any other purpose The product consists of a tube for connection to the endoscope and over-tube and balloon controller, and a filter. This product is supplied non-sterile. Also, The filter is a single patient use item. Prepare a new filter before use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410324280 FDA UDI
- FDA Product Code
- FDF FDA UDIFDA FDA UDI
- GMDN Term
- Medical air low pressure hose 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical air low pressure hose
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- FUJIFILM Corporation
Sources (1)
- FDA UDI ee0a8291-47ef-4c68-8482-167e5e5adc56 35 fields · synced Jun 1, 2026