Identity
- Trade Name
- TUB10 FDA UDI
- Generic Name
- Vacuum-assisted airway secretion-clearing system FDA UDI
- Device Name
- Single patient use expiratory kit TUB10 FDA UDI
- Model / Reference
- TUB-10 FDA UDI
- Description
- Single patient use expiratory kit TUB10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664224000023 FDA UDI
- FDA Product Code
- SDT FDA UDI
- GMDN Term
- Vacuum-assisted airway secretion-clearing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vacuum-assisted airway secretion-clearing system
Tub10 by Physio-Assist — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-assisted airway secretion-clearing system.
- Drive DeVilbiss Vacu-Aide Sunciton Unit — Drive Devilbiss Healthcare · Class II
- Drive DeVilbiss Vacu-Aide Suction Unit — Drive Devilbiss Healthcare · Class II
- TUB25 — PHYSIO-ASSIST
- SIMEOX 200 — PHYSIO-ASSIST · Class II
- SIMEOX 200 — PHYSIO-ASSIST · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Physio-Assist
Sources (1)
- FDA UDI 4edf964f-1940-4755-ad44-97bfce4c4212 34 fields · synced May 30, 2026