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Express

FDA UDI

Class II (US FDA UDI)

by Atrium Medical Corp.

Identity

Trade Name
EXPRESS FDA UDI
Generic Name
Thoracic suction collection container FDA UDI
Device Name
EXPRESS DRAIN, SINGLE, INLINE & ATS COMPATIBLE FDA UDI
Model / Reference
4000-100N FDA UDI
Description
EXPRESS DRAIN, SINGLE, INLINE & ATS COMPATIBLE FDA UDI

Identifiers

Primary DI / UDI-DI
00650862115130 FDA UDI
510(k) Number
K043140 FDA UDI
FDA Product Code
KDQ FDA UDI
GMDN Term
Thoracic suction collection container FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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
MRI Safety
MR Conditional FDA UDI

Category: Thoracic suction collection container

Express by Atrium Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thoracic suction collection container.

Cleared under the same submission

K043140 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atrium Medical Corp.

Sources (1)

  • FDA UDI 26397c76-d24b-46b1-ac66-6b051be02d39 35 fields · synced Jun 1, 2026