ProCell Surgical Sponge-Blood Recovery Unit

Basic Information

• Brand Name: ProCell Surgical Sponge-Blood Recovery Unit
• Primary DI: B890SBRU011
• Version / Model: SBRU-01
• Catalog Number: SBRU-01
• Company Name: Procell Surgical (us) Inc.
• Labeler DUNS: 117681877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-01
• Public Version: 3
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 5fb6f232-aeaa-4632-b99c-57f19c68a8d1

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAC	Apparatus, Autotransfusion	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B890SBRU011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193361	000