TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive

Basic Information

• Brand Name: TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive
• Primary DI: 07332834000257
• Version / Model: TC 555
• Company Name: Perimed AB
• Labeler DUNS: 354765570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2017-02-14
• Public Version: 4
• Public Version Date: 2021-05-21
• Public Version Status: Update
• Public Device Record Key: 397bbff8-f435-4250-8f11-b80f16d13020

Device Description

TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	868.2480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46934	Transcutaneous blood gas monitoring system	An assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332834000257	GS1
Unit of Use	07332834000233	GS1

Premarket Submissions

Submission Number	Supplement Number
K990960	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity