Duns Number:117681877
Device Description: ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary stepin ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary stepin the process of cell- salvage/intra-operative autotransfusion (IAT).ProCell™ functions as a blood collection device only and does not filter or otherwiseprocess the blood recovered. As an accessory to IAT, it is used in conjunction withstandard 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 disposableProCell™ can be used repeatedly during a surgical case and provides an alternative toother sponge-blood recovery methods including hand-wringing.
Catalog Number
SBRU-01
Brand Name
ProCell Surgical Sponge-Blood Recovery Unit
Version/Model Number
SBRU-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193361
Product Code
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
5fb6f232-aeaa-4632-b99c-57f19c68a8d1
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
December 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |