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Aqua-Seal

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Aqua-Seal FDA UDI
Generic Name
Autotransfusion system blood collection container FDA UDI
Device Name
Aqua-Seal Chest Drainage Unit Wet Suction, Dual Drain FDA UDI
Model / Reference
8888571406 FDA UDI
Description
Aqua-Seal Chest Drainage Unit Wet Suction, Dual Drain FDA UDI

Identifiers

Catalog Number
8888571406 FDA UDI
Primary DI / UDI-DI
10884521061002 FDA UDI
FDA Product Code
GCX FDA UDI
GMDN Term
Autotransfusion system blood 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

Yes

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 Unsafe FDA UDI

Category: Autotransfusion system blood collection container

Aqua-Seal by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autotransfusion system blood collection container.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI efe062f7-277a-4cf2-aef3-0ea69d6672aa 35 fields · synced Jun 8, 2026