Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)

Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001)
Triton Canister System - PN 11033

A device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PBZ

Device Name: Image Processing Device For Estimation Of External Blood Loss

Device Class: 2

Physical State: Software and Hardware system.

Definition: An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: General Surgery

Regulation Number: 880.2750

Third Party Flag: N

Medical Specialty: HO

Device Id: 00859506006104

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A