Multi-Site Attachment Ring for fragile/sensitive s

GUDID 07640121880230

MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but 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

Primary Device ID	07640121880230
NIH Device Record Key	92a2f6fe-166b-424f-8366-228cab45ffe2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Multi-Site Attachment Ring for fragile/sensitive s
Version Model Number	MAR-SF
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

Special Storage Condition, Specify	Between 0 and 0 *during transport: 0-50°C
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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 *during transport: 0-50°C
Storage Environment Humidity	Between 30 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	07640121880230 [Primary]
GS1	17640121880237 [Package] Package: Box [24 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

DPZ	Oximeter, Ear

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-31

On-Brand Devices [Multi-Site Attachment Ring for fragile/sensitive s]

17640121880800	Single use sensor application ring, recommended for adult, pediatric and neonatal patients with
07640121880230	MAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with se