Identity
- Trade Name
- DeVilbiss FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- Vacu-Aide QSU, North America FDA UDI
- Model / Reference
- 7314D-D FDA UDI
- Description
- Vacu-Aide QSU, North America FDA UDI
Identifiers
- Catalog Number
- 7314D-D FDA UDI
- Primary DI / UDI-DI
- 00885304000587 FDA UDI
- 510(k) Number
- K982304 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- General-purpose suction system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
FDA UDI
Category: General-purpose suction system, line-powered
DeVilbiss by DeVilbiss Healthcare LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose suction system, line-powered.
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- Winx® — Apnicure, Inc. · Class II
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- Snorkel — Neotech Products LLC · Class II
- ANGIOJET — Bayer Healthcare · Class III
- Winx® — Apnicure, Inc. · Class II
Cleared under the same submission
K982304 also covers:
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- DeVilbiss — DeVilbiss Healthcare LLC.
- Drive DeVilbiss Vacu-Aide Suction Unit — Drive Devilbiss Healthcare
- Drive DeVilbiss Vacu-Aide Sunciton Unit — Drive Devilbiss Healthcare
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 |
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Manufacturer
- Manufacturer
- DeVilbiss Healthcare LLC.
Sources (1)
- FDA UDI 13a85d0b-b990-4952-a696-a24e3e42a033 37 fields · synced May 31, 2026