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

GUDID

Device Identifier (DI) Information

Brand Name: ProCell Surgical Sponge-Blood Recovery Unit
Version or Model: SBRU-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SBRU-01
Company Name: Procell Surgical (us) Inc.

Primary DI Number: B890SBRU011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117681877 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, Autotransfusion

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fb6f232-aeaa-4632-b99c-57f19c68a8d1
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: December 01, 2020