Identity
- Trade Name
- Axiom® Dual-Sump FDA UDI
- Generic Name
- Sump drain FDA UDI
- Device Name
- Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring FDA UDI
- Model / Reference
- 111196SR FDA UDI
- Description
- Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring FDA UDI
Identifiers
- Primary DI / UDI-DI
- M665111196SR0 FDA UDI
- 510(k) Number
- K771048 FDA UDI
- FDA Product Code
- FEG FDA UDI
- GMDN Term
- Sump drain FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 8.5 Millimeter FDA UDILength — 20 Inch FDA UDI
Category: Sump drain
Axiom® Dual-Sump by Axiom Medical, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sump drain.
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- Salem Sump — Cardinalhealth · Class II
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- Argyle — Cardinalhealth · Class I
- Kangaroo — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K771048 also covers:
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Dual-Sump — AXIOM MEDICAL, INCORPORATED
- Axiom® Hacienda Sump® — AXIOM MEDICAL, INCORPORATED
- Axiom® Hacienda Sump® — AXIOM MEDICAL, INCORPORATED
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
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI baa8fc4a-d4d7-44b0-a1f6-18c9cfcc10aa 36 fields · synced Jun 8, 2026