Simplified Sleep Stage Evaluation for SOMNOtouch RESP

Basic Information

• Brand Name: Simplified Sleep Stage Evaluation for SOMNOtouch RESP
• Primary DI: 04250413404056
• Version / Model: TOS051
• Company Name: SOMNOmedics GmbH
• Labeler DUNS: 314112173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-12
• Public Version: 1
• Public Version Date: 2019-04-22
• Public Version Status: New
• Public Device Record Key: b21d5e88-d7dc-495d-b71d-c3ed22023610

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
13085	Polygraph	A multichannel physiologic graphic recorder designed for the simultaneous recording of a number of different physiologic parameters, e.g., electrocardiogram (ECG), blood pressure, electroencephalogram (EEG), temperature or respiration. This device is frequently used for testing the truth of a person's statements (i.e., used as a "lie detector").	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250413404056	GS1

Premarket Submissions

Submission Number	Supplement Number
K140861	000