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Brat 2

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
BRAT 2 FDA UDI
Generic Name
Blood autotransfusion system tubing FDA UDI
Model / Reference
SUCTION ASSEMBLY - 20ft (Twist Lock) FDA UDI

Identifiers

Primary DI / UDI-DI
08033178109499 FDA UDI
510(k) Number
K974897 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Blood autotransfusion system tubing 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

No

FDA UDI

Category: Blood autotransfusion system tubing

Brat 2 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

K974897 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 0a44442a-1f60-4a6e-9f1d-2632fb32cd5c 33 fields · synced May 30, 2026