Identity
- Trade Name
- Suction Unit with Base FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Model / Reference
- 10821 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784082110 FDA UDI
- 510(k) Number
- K042349 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Surgical suction system collection container, single-use 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
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Surgical suction system collection container, single-use
Suction Unit with Base by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical suction system collection container, single-use.
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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
- Dynarex Corp.
Sources (1)
- FDA UDI 81752bb0-78d7-4434-a43b-dd9219fc5fcc 33 fields · synced May 30, 2026