Identity
- Trade Name
- DRIVEMEDICAL FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- RespiratoryNebs Product Description: Panda w/Rx Form (115014), 1/ea,6/cv FDA UDI
- Model / Reference
- 4057IMEDS FDA UDI
- Description
- RespiratoryNebs Product Description: Panda w/Rx Form (115014), 1/ea,6/cv FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383524467 FDA UDI
- 510(k) Number
- K031413 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Therapeutic agent nebulizer, benchtop
Revolutionize your patient care with the DRIVEMEDICAL, a high-quality therapeutic agent nebulizer designed for home and clinical use. This device is ideal for treating respiratory disorders such as COPD and CF, providing precise aerosolization of medications or fluids via non-heat-dependent methods.
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Cleared under the same submission
K031413 also covers:
- LEADER — Cardinal Health 110, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- JOHN BUNN — GF Health Products, Inc
- JOHN BUNN — GF Health Products, Inc
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 bffd629f-f04e-4d62-995e-d9646c1adde5 34 fields · synced Jul 23, 2026