Identity
- Trade Name
- basixSKY™ FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Model / Reference
- Initial Release FDA UDI
Identifiers
- Catalog Number
- SKY1302 FDA UDI
- Primary DI / UDI-DI
- 10884450822514 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
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
Introducing the basixSKY, a cutting-edge medical device designed to safely and efficiently inflate and regulate the pressure of invasive devices like catheter overtubes. With its simple yet effective mechanism, this single-use device is ideal for various medical applications.
Similar devices
Also classified as Catheter/overtube balloon inflator, single-use.
- GENOSS Inflator B40 — Genoss · Class II
- AngioDynamics — NAVILYST MEDICAL, INC.
- NuVent™ — MEDTRONIC XOMED, INC. · Class I
- QL Disposable Inflation Device — Atrion Medical Products, Inc. · Class II
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC. · Class II
- 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
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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI fe31e405-8d91-4e96-8766-ec6574548e4d 33 fields · synced Oct 6, 2026