Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Alternating-pressure bed mattress FDA UDI
- Device Name
- MATTRESS,EQUALIZEAIRE 12000,35X84 PUMP FDA UDI
- Model / Reference
- MDTE12C3584P FDA UDI
- Description
- MATTRESS,EQUALIZEAIRE 12000,35X84 PUMP FDA UDI
Identifiers
- Catalog Number
- MDTE12C3584P FDA UDI
- Primary DI / UDI-DI
- 10080196379934 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure bed mattress FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating-pressure bed mattress
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alternating-pressure bed mattress.
- Platinum 6000 Alliance Mattress — SIZEWISE RENTALS, L.L.C. · Class II
- Mercury Advance Mattress — THE KIRTON HEALTHCARE GROUP LIMITED · Class II
- Dual Core Foam Mattress Family — SIZEWISE RENTALS, L.L.C. · Class II
- ProMatt Plus — Joerns Healthcare · Class II
- ProMatt Plus — Joerns Healthcare · Class II
- PANACEA AIR MAX MATTRESS FAMILY — SIZEWISE RENTALS, L.L.C. · Class II
- Instant Comfort M6/M8 Mattress Family — SIZEWISE RENTALS, L.L.C. · Class II
- ProMatt Plus — Joerns Healthcare · 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI cd1ed075-d51e-4e59-bcb5-d563d61d6412 35 fields · synced May 31, 2026