Genesis DM w ST NIBP 2

GUDID 00817644020116

RESIDEO LIFE CARE SOLUTIONS LLC

Home healthcare information system

• Primary Device ID: 00817644020116
• NIH Device Record Key: 215dc12e-0e35-438a-a5d2-15557abe0b3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis DM w ST NIBP 2
• Version Model Number: 6053000RE1
• Company DUNS: 081631991
• Company Name: RESIDEO LIFE CARE SOLUTIONS LLC
• 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: false
• Serial Number: true
• 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	00817644020116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101242

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-25
• Device Publish Date: 2017-10-26

Devices Manufactured by RESIDEO LIFE CARE SOLUTIONS LLC

• 00817644020161 - Genesis Touch Tab A 8.4 - RCT: 2021-04-08
• 00817644020178 - Genesis Touch Tab A 8.4: 2020-07-01
• 00817644020154 - Genesis Touch TAB E ATT: 2019-05-22
• 00817644020000 - LifeStream Application: 2019-02-25
• 00817644020017 - Genesis Touch TAB E: 2019-02-25
• 00817644020024 - Genesis Touch Application: 2019-02-25
• 00817644020031 - Genesis Touch TAB 4: 2019-02-25
• 00817644020048 - Genesis DM Pro BP: 2019-02-25