Identity
- Trade Name
- Drive FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Heavy Duty Suction Machine FDA UDI
- Model / Reference
- 18600 FDA UDI
- Description
- Heavy Duty Suction Machine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383111377 FDA UDI
- 510(k) Number
- K042349 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
No
FDA UDI
Category: Airway suction catheter
Drive by Drive Devilbiss Healthcare — 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
K042349 also covers:
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- Schuco — Allied Medical LLC
- DRIVEMEDICAL — Drive Devilbiss Healthcare
- Drive — Drive Devilbiss Healthcare
- Resp-O2 Suction Unit With Base, Vacuum Levels up to 560 mmHg — Dynarex Corp.
- Resp-O2 Suction Unit, Vacuum Levels up to 560 mmHg — Dynarex Corp.
- Suction Unit — Dynarex Corp.
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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 71cd63ca-9cd1-47f0-8307-0f561a240138 34 fields · synced Jun 8, 2026