Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- ASPIRATOR,SUCTION,W/800CC CANISTER FDA UDI
- Model / Reference
- HCS7000 FDA UDI
- Description
- ASPIRATOR,SUCTION,W/800CC CANISTER FDA UDI
Identifiers
- Catalog Number
- HCS7000 FDA UDI
- Primary DI / UDI-DI
- 40080196769293 FDA UDI
- 510(k) Number
- K042349 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose surgical suction system, vacuum
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose surgical suction system, vacuum.
- Drager — Allied Medical LLC · Class II
- Phantom — Innovative Med, Inc. · Class II
- AURORA Evacuator — REBOUND THERAPEUTICS, CORPORATION · Class II
- GOMCO — Allied Medical LLC · Class II
- Orthopaedic Suction Set — GCMEDICA ENTERPRISE LTD.(WUXI) · Class II
- Schuco — Allied Medical LLC · Class II
- ADULT TIP SUCKER HEX HANDLE WITH VENT — NOVOSCI CORP. · Class II
- XinjingProWellness™ — Tianjin Newtrans Technology Development · Class II
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
- 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.
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI d90f63c1-bf01-479d-98c2-165ec6051b76 37 fields · synced Jun 8, 2026