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ATO Oxygenator line

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name
ATO Oxygenator line FDA UDI
Generic Name
Autotransfusion system blood component processing set FDA UDI
Device Name
ATO Oxygenator line is a tubing system to connect an oxygenator with one fourth inch male connector to an Autotransfusion device. FDA UDI
Model / Reference
9108434 FDA UDI
Description
ATO Oxygenator line is a tubing system to connect an oxygenator with one fourth inch male connector to an Autotransfusion device. FDA UDI

Identifiers

Catalog Number
9108434 FDA UDI
Primary DI / UDI-DI
04052682000621 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Autotransfusion system blood component processing set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5830 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

Yes

FDA UDI

Category: Autotransfusion system blood component processing set

ATO Oxygenator line by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autotransfusion system blood component processing set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA UDI 9822e2bc-e4d0-4e12-a41b-86ea2bf22b2e 36 fields · synced May 30, 2026