Identity
- Trade Name
- Aquilo Sports FDA UDI
- Generic Name
- External cuff/pad inflation tubing set, reusable FDA UDI
- Model / Reference
- Air Tube - Dual FDA UDI
Identifiers
- Catalog Number
- AQU655 AT2 FDA UDI
- Primary DI / UDI-DI
- 00850009827272 FDA UDI
- 510(k) Number
- K223164 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- External cuff/pad inflation tubing set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External cuff/pad inflation tubing set, reusable
Aquilo Sports by Aquilo Sports L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External cuff/pad inflation tubing set, reusable.
- AQUARI TUBING SET TWO-LINE HOOKUP — Mizuho Orthopedic Systems, Inc. · Class II
- Aquilo Sports — AQUILO SPORTS L.L.C. · Class II
Cleared under the same submission
K223164 also covers:
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
- Aquilo Sports — AQUILO SPORTS L.L.C.
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
- Aquilo Sports L.l.c.
Sources (1)
- FDA UDI ef116474-ba6a-4562-9b60-f45adbbfce58 34 fields · synced May 30, 2026