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.
SBRU-01
In Commercial Distribution
SBRU-01
Procell Surgical (us) Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
No | |
No | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAC | Apparatus, Autotransfusion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K193361 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5fb6f232-aeaa-4632-b99c-57f19c68a8d1
June 02, 2023
3
December 01, 2020
June 02, 2023
3
December 01, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
617-849-7900
customerservice@procellsi.com
customerservice@procellsi.com