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Autotransfusion Accessories

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
AUTOTRANSFUSION ACCESSORIES FDA UDI
Generic Name
Blood autotransfusion system tubing FDA UDI
Model / Reference
BT074 COD.131 FDA UDI

Identifiers

Primary DI / UDI-DI
08033178105484 FDA UDI
510(k) Number
K872159 FDA UDI
FDA Product Code
DNF FDA UDI
GMDN Term
Blood autotransfusion system tubing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3380 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: Blood autotransfusion system tubing

Autotransfusion Accessories by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood autotransfusion system tubing.

Cleared under the same submission

K872159 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sorin Group Italia Srl

Sources (1)

  • FDA UDI a5c5a6a6-9c35-4651-9754-b3e0cd291fb4 33 fields · synced Jun 6, 2026