Identity
- Trade Name
- Drive FDA UDI
- Generic Name
- Low-air-loss bed FDA UDI
- Device Name
- Pressure Prevention Group 2 Surfaces Product Description ES MedAire Bari AP LAL system w pump 42" FDA UDI
- Model / Reference
- GV34030 FDA UDI
- Description
- Pressure Prevention Group 2 Surfaces Product Description ES MedAire Bari AP LAL system w pump 42" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383013008 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Low-air-loss bed 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Low-air-loss bed
Drive by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low-air-loss bed.
- K-6oem AIRE-TURN ASSIST — KAP MEDICAL · Class II
- K-4 D³X — KAP MEDICAL · Class II
- K-2oem ALT-AIRE+ — KAP MEDICAL · Class II
- K-4IM IntelliMatt — KAP MEDICAL · Class II
- K-Zoem EZ-TURN — KAP MEDICAL · Class II
- K-0 ECO-ZONE — KAP MEDICAL · Class II
- K-2oem ALT-AIRE+ — KAP MEDICAL · Class II
- K-4 D³X — KAP MEDICAL · 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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 0b3862ff-5a13-49ac-afcf-a506a0de620a 33 fields · synced Jun 8, 2026