Identity
- Trade Name
- Axiom® MultiPurpose Atraum™ With ClotStop® FDA UDI
- Generic Name
- Sump drain FDA UDI
- Device Name
- Sump Drain, Two Lumens, Silicone, Splittable, With ClotStop® FDA UDI
- Model / Reference
- 110218AT FDA UDI
- Description
- Sump Drain, Two Lumens, Silicone, Splittable, With ClotStop® FDA UDI
Identifiers
- Primary DI / UDI-DI
- M665110218AT0 FDA UDI
- 510(k) Number
- K993592 FDA UDI
- FDA Product Code
- BSO FDA UDI
- GMDN Term
- Sump drain FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 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
Category: Sump drain
Axiom® MultiPurpose Atraum™ With ClotStop® by Axiom Medical, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sump drain.
- Salem Sump — Cardinalhealth · Class II
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- Thoraguard — Centese, Inc. · Class I
- Salem Sump — Cardinalhealth · Class II
- MedDrain — ARMM INC. · Class I
- Salem Sump — Cardinal Health 200, LLC · Class II
- Argyle — Cardinalhealth · Class I
- Kangaroo — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K993592 also covers:
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 b0ae6253-0c96-4e10-b492-782a78990e3e 36 fields · synced May 30, 2026