Multi-Site Attachment Ring for mature/intact skin

GUDID 07640121880797

Single use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin

SenTec AG

Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880797
• NIH Device Record Key: 9e0f4315-9460-454f-acfe-0612db0778b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Site Attachment Ring for mature/intact skin
• Version Model Number: MARe-MI
• Company DUNS: 480797856
• Company Name: SenTec AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Temperature during transport: 0-50°C
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880797 [Primary]
GS1	17640121880794 [Package]; Package: Box [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

• LPP: Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-02
• Device Publish Date: 2019-01-29

On-Brand Devices [Multi-Site Attachment Ring for mature/intact skin]

• 07640121880797: Single use sensor application ring, recommended for adult, pediatric and neonatal patients with
• 07640121880223: MAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with ma