Identity
- Trade Name
- Axiom® MultiPurpose FDA UDI
- Generic Name
- Sump drain FDA UDI
- Device Name
- Sump Drain, Two Lumens, Silicone, Splittable FDA UDI
- Model / Reference
- 110218 FDA UDI
- Description
- Sump Drain, Two Lumens, Silicone, Splittable FDA UDI
Identifiers
- Primary DI / UDI-DI
- M6651102180 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 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
- Salem Sump — Cardinalhealth · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI 1bfd0454-3c4a-4923-a0a5-bd7faed3bd70 36 fields · synced Jun 1, 2026