Identity
- Trade Name
- basixTOUCH™ FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Model / Reference
- 00884450292945 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450292945 FDA UDI
- FDA Product Code
- PTM FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Catheter/overtube balloon inflator, single-use
BasixTOUCH is a reliable and user-friendly catheter/overtube balloon inflator designed for single-use medical procedures. This device is used to inflate and regulate the pressure of invasive devices, such as tamp or endomicroscopy probes. With its intuitive design and accurate monitoring features, BasixTOUCH ensures safe and effective use in clinical settings.
Similar devices
Also classified as Catheter/overtube balloon inflator, single-use.
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- AngioDynamics — NAVILYST MEDICAL, INC.
- Encore 40 Inflation Device — Atrion Medical Products, Inc. · Class II
- GM-30 Inflation Device — Infraredx, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 8ba9ef14-01c5-4f96-a477-9d23a622b86d 32 fields · synced Oct 6, 2026