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ProCell Surgical Sponge-Blood Recovery Unit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SBRU-01

by Procell Surgical (us) Inc.

Identity

Trade Name
ProCell Surgical Sponge-Blood Recovery Unit FDA UDI
Generic Name
Autotransfusion system blood collection container FDA UDI
Device Name
ProCell Sponge Blood Recovery Unit EUDAMED
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of cell- salvage/intra-operative autotransfusion (IAT). ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard cell-salvage equipment which must process the blood retrieved from ProCell™ prior to re-infusion into the patient. Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing. FDA UDI
Model / Reference
SBRU-01 EUDAMEDFDA UDI
Description
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of cell- salvage/intra-operative autotransfusion (IAT). ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard cell-salvage equipment which must process the blood retrieved from ProCell™ prior to re-infusion into the patient. Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing. FDA UDI

Identifiers

Catalog Number
SBRU-01 FDA UDI
Primary DI / UDI-DI
00860006628406 EUDAMED
B890SBRU011 FDA UDI
Basic UDI-DI
++B890SBRU012V EUDAMED
510(k) Number
K193361 FDA UDI
FDA Product Code
CAC FDA UDI
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
GMDN Term
Autotransfusion system blood collection container FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.5830 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 collection container

ProCell Surgical Sponge-Blood Recovery Unit by Procell Surgical (us) Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Autotransfusion system blood collection container.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Procell Surgical (us) Inc.

Sources (2)

  • FDA UDI 5fb6f232-aeaa-4632-b99c-57f19c68a8d1 36 fields · synced Aug 1, 2026
  • EUDAMED f828b63a-9fb5-4fa1-89d0-6e7e3acc678a 61 fields · synced Aug 1, 2026