Identity
- Trade Name
- TheraFlo M-set 42'' × 80'' QLT Sentech FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay, reusable FDA UDI
- Device Name
- TheraFlo M-set 42'' × 80'' QLT Sentech FDA UDI
- Model / Reference
- S2001-2230 FDA UDI
- Description
- TheraFlo M-set 42'' × 80'' QLT Sentech FDA UDI
Identifiers
- Catalog Number
- 3001003 FDA UDI
- Primary DI / UDI-DI
- 00841965103838 FDA UDI
- FDA Product Code
- IOQ FDA UDI
- GMDN Term
- Alternating-pressure bed mattress overlay, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5170 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Alternating-pressure bed mattress overlay, reusable
TheraFlo M-set 42'' × 80'' QLT Sentech by Tridien Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alternating-pressure bed mattress overlay, reusable.
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- MERIDIAN MEDICAL — COMPASS HEALTH BRANDS CORP. · Class II
- Dabir Micropressure — DABIR SURFACES, INC. · Class II
- Dabir Micropressure — DABIR SURFACES, INC. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- Guardian — TURNCARE, INC. · Class II
- Drive — Drive Devilbiss Healthcare · Class I
- Medline — MEDLINE INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tridien Medical
Sources (1)
- FDA UDI ec2121a4-f71e-40b1-8a77-d09783556c91 35 fields · synced May 30, 2026