Identity
- Trade Name
- Pneumatic Inflator FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, reusable FDA UDI
- Device Name
- Pneumatic Inflator FDA UDI
- Model / Reference
- M00553200 FDA UDI
- Description
- Pneumatic Inflator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729195450 FDA UDI
- FDA Product Code
- GBA FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Catheter/overtube balloon inflator, reusable
Pneumatic Inflator by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter/overtube balloon inflator, reusable.
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- NaviAid™ SPARK — SMART MEDICAL SYSTEMS LTD · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- NaviAid™ SPARKC — SMART MEDICAL SYSTEMS LTD · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 6ce54de3-a346-4349-b4d2-7de89e0256d7 33 fields · synced May 30, 2026