- Physicians Office Resource

Pediatric SomaSensor
INVOS - SPFB/INTL

Device Description

A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Patient Weight,< 40,Kilogram;

Patient Weight,< 40,Kilogram;

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: MUD

Device Name: Oximeter, Tissue Saturation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2700

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 10884521105911

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521105918

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884521105918

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

Device Id: 10884521552708

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521105911

Package Quantity: 56

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

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