SOMNOtouch RESP accessory

GUDID 04250413404094

SOMNOmedics GmbH

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system

• Primary Device ID: 04250413404094
• NIH Device Record Key: 7861db2d-d458-4a9f-aa98-2f63b763a06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOMNOtouch RESP accessory
• Version Model Number: TOS020
• Company DUNS: 314112173
• Company Name: SOMNOmedics GmbH
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250413404094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140861

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2016-09-19

On-Brand Devices [SOMNOtouch RESP accessory]

• 04250413405022: TOS010
• 04250413404544: TOS012
• 04250413404469: TOS095
• 04250413404339: TOS062
• 04250413404322: TOS060
• 04250413404223: TOS808
• 04250413404216: TOS807
• 04250413404209: TOS806
• 04250413404193: TOS805
• 04250413404186: TOS803
• 04250413404179: TOS802
• 04250413404162: TOS801
• 04250413404155: TOS800
• 04250413404094: TOS020
• 04250413404087: TOS011
• 04250413410859: TOS011S
• 04250413410842: TOS175S
• 04250413410835: TOS110S