Identity
- Trade Name
- LUMEX FDA UDI
- Generic Name
- Alternating-pressure inflator FDA UDI
- Device Name
- AltaDyne Alternating Pressure/Low Air Loss Pump FDA UDI
- Model / Reference
- 750000P FDA UDI
- Description
- AltaDyne Alternating Pressure/Low Air Loss Pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- M368750000P1 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure inflator 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating-pressure inflator
Lumex by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alternating-pressure inflator.
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- Dolphin Control Unit — Joerns Healthcare · Class II
- ArroAir Pro Bariatric 14LPM Pump — ARROWHEAD HEALTHCARE SUPPLY, LLC · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- TurnCair — Joerns Healthcare · Class II
- Stratus Pump 5.1 (110 V) — SIZEWISE RENTALS, L.L.C. · Class I
- American Bantex — COMPASS HEALTH BRANDS CORP. · Class II
- Platinum 6000 Control Unit — SIZEWISE RENTALS, L.L.C. · Class I
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
- GF Health Products, Inc
Sources (1)
- FDA UDI 06fa7c5f-2104-4e05-aee7-c47a3044bc04 35 fields · synced Jun 6, 2026