Identity
- Trade Name
- DeVilbiss FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Homecare Suction, North America FDA UDI
- Model / Reference
- 7305D-D FDA UDI
- Description
- Homecare Suction, North America FDA UDI
Identifiers
- Catalog Number
- 7305D-D FDA UDI
- Primary DI / UDI-DI
- 00853040023382 FDA UDI
- 510(k) Number
- K982304 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Airway suction catheter 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: Airway suction catheter
DeVilbiss by DeVilbiss Healthcare LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Airway suction catheter.
- AirLife™ — Airlife, Inc. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Little Sucker Standard TP — Neotech Products LLC · Class II
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 335ae103-9f58-445a-843c-73c93149ca35 36 fields · synced May 31, 2026