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Axiom® Atraum™ With ClotStop®

FDA UDI

Class I (US FDA UDI)

by Axiom Medical, Incorporated

Identity

Trade Name
Axiom® Atraum™ With ClotStop® FDA UDI
Generic Name
Pleural catheter FDA UDI
Device Name
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop® FDA UDI
Model / Reference
100036ATS FDA UDI
Description
Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop® FDA UDI

Identifiers

Primary DI / UDI-DI
M665100036ATS0 FDA UDI
510(k) Number
K883887 FDA UDI
FDA Product Code
GBS FDA UDI
GMDN Term
Pleural catheter 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

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: Pleural catheter

Axiom Atraum With ClotStop device is a medical device designed to establish channels for the removal of fluid, air, or pus from the pleural cavity, typically after surgery or chest trauma. It is made of silicone and includes a low negative pressure through the drain lumen. The device is available in various designs, shapes, and sizes, including disposable devices dedicated to catheter introduction.

Similar devices

Also classified as Pleural catheter.

Cleared under the same submission

K883887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axiom Medical, Incorporated

Sources (1)

  • FDA UDI 99d58608-ef84-4901-b6ac-9b3ebd3fcbf7 36 fields · synced Jun 19, 2026