Identity
- Trade Name
- Axiom® Atraum™ With ClotStop® FDA UDI
- Generic Name
- Mediastinal drainage catheter, non-antimicrobial FDA UDI
- Device Name
- Mediastinal Drain, Silicone, Eyes On Sides, With ClotStop® FDA UDI
- Model / Reference
- 111115AT FDA UDI
- Description
- Mediastinal Drain, Silicone, Eyes On Sides, With ClotStop® FDA UDI
Identifiers
- Primary DI / UDI-DI
- M665111115AT0 FDA UDI
- 510(k) Number
- K883887 FDA UDI
- FDA Product Code
- GBS FDA UDI
- GMDN Term
- Mediastinal drainage catheter, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Mediastinal drainage catheter, non-antimicrobial
Axiom® Atraum™ With ClotStop® by Axiom Medical, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mediastinal drainage catheter, non-antimicrobial.
- Flexima™ APD™ — Boston Scientific · Class II
- Thoraguard — Centese, Inc. · Class I
- Pleuraflow® System with FlowGlide — CLEARFLOW, INC · Class II
- MedDrain — ARMM INC. · Class I
- PleuraFlow® System with FlowGlide — CLEARFLOW, INC · Class II
- Flexima™ APDL — Boston Scientific · Class II
- Flexima™ Quickstick™ — Boston Scientific · Class II
- Thoracic Drain — LivaNova USA, Inc. · Class I
Cleared under the same submission
K883887 also covers:
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — AXIOM MEDICAL, INCORPORATED
- Axiom® Atraum™ With ClotStop® — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Axiom Medical, Incorporated
Sources (1)
- FDA UDI 6e684aa3-ec12-4856-84d2-a2349cedc711 36 fields · synced May 30, 2026