DEVICE: ProCell Surgical Sponge-Blood Recovery Unit (B890SBRU011)

Device Identifier (DI) Information

ProCell Surgical Sponge-Blood Recovery Unit
SBRU-01
In Commercial Distribution
SBRU-01
Procell Surgical (us) Inc.
B890SBRU011
HIBCC

1
117681877 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36966 Autotransfusion system blood collection container
A receptacle intended to be used for the collection of autologous blood from a patient in conjunction with a dedicated pump and tubing set (not included) as part of an autotransfusion procedure. It typically includes a lid and short connection tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAC Apparatus, Autotransfusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K193361 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5fb6f232-aeaa-4632-b99c-57f19c68a8d1
June 02, 2023
3
December 01, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
617-849-7900
customerservice@procellsi.com
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