PHILIPS Transcutaneous pO2/pCO2 Parameter Module

Basic Information

• Brand Name: PHILIPS Transcutaneous pO2/pCO2 Parameter Module
• Primary DI: 00884838021006
• Version / Model: 862283
• Catalog Number: 862283
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Labeler DUNS: 314101143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-02
• Public Version: 4
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 32daf90a-9f0e-4e2d-9ae5-cbd06392e327

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLK	Monitor, oxygen, cutaneous, for infant not under gas anesthesia	Anesthesiology	868.2500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36898	Patient monitoring system module, blood gas, transcutaneous	A small unit dedicated to the measurement of blood gas tensions for the partial pressure of oxygen (pO2) and partial pressure of carbon dioxide (pCO2) transcutaneously (through the skin) in a patient's blood using a special sensor which is typically heated to improve local vascularity. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pO2/pCO2 signals measured and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838021006	GS1

Customer Contacts

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