Identity
- Trade Name
- RESERVOIR TANK FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, reusable FDA UDI
- Device Name
- MAJ-1727 OBCU RESERVOIR TANK FDA UDI
- Model / Reference
- MAJ-1727 FDA UDI
- Description
- MAJ-1727 OBCU RESERVOIR TANK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170239571 FDA UDI
- FDA Product Code
- FED FDA UDIFDA FDA UDINWB FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, 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
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: Catheter/overtube balloon inflator, reusable
Reservoir Tank by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter/overtube balloon inflator, reusable.
- NaviAid™ SPARK — SMART MEDICAL SYSTEMS LTD · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Pneumatic Inflator — Boston Scientific · Class I
- NaviAid™ SPARKC — SMART MEDICAL SYSTEMS LTD · Class II
- BALLOON CONTROL UNIT — Olympus Medical Systems Corporation · 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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 27b7a563-0951-4162-89e4-8ff39a2ae4cd 34 fields · synced Jun 8, 2026