Patient Application Kit for mature intact skin

Basic Information

• Brand Name: Patient Application Kit for mature intact skin
• Primary DI: 07640121880964
• Version / Model: PAK-MI
• Company Name: SenTec AG
• Labeler DUNS: 480797856
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-26
• Public Version: 2
• Public Version Date: 2024-01-26
• Public Version Status: Update
• Public Device Record Key: f2b14699-1605-4eee-b0d9-ddbfbf265599
• Distribution End Date: 2024-01-25

Device Description

A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	868.2500	2
DPZ	Oximeter, Ear	Cardiovascular	870.2710	2
DQA	Oximeter	Cardiovascular	870.2700	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
37178	Transcutaneous blood gas monitor sensor	A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.	No	Active
47582	Pulse Co-oximeter probe, reusable	A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17640121880961	GS1	Box	12	Not in Commercial Distribution	2024-01-25
Primary	07640121880964	GS1

Premarket Submissions

Submission Number	Supplement Number
K041548	000
K071672	000
K101690	000
K151329	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 25 – 60 Percent (%) Relative Humidity