SOBERLINK

GUDID B901GSM20

SOBERLINK HEALTHCARE LLC

Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser

• Primary Device ID: B901GSM20
• NIH Device Record Key: 7b71255e-2748-44f7-8550-d07f2d1b56dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOBERLINK
• Version Model Number: SOBERLINK GSM2
• Company DUNS: 079871438
• Company Name: SOBERLINK HEALTHCARE 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B901GSM20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160613

FDA Product Code

• DJZ: Devices, Breath Trapping, Alcohol

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [SOBERLINK]

• B901GSM2REFURB0: SOBERLINK GSM2 REFURB
• B901GSM20: SOBERLINK GSM2
• B901GSM1REFURB0: SOBERLINK GSM1 REFURB
• B901CONNECTREFURB0: SOBERLINK CONNECT REFURB
• B901CONNECT0: CONNECT
• B90105: SOBERLINK GSM1 REFURB - 05
• B90104: SOBERLINK GSM2 REFURB - 04
• B90103: SOBERLINK Connect REFURB - 03
• B90102: SOBERLINK GSM2 - 02
• B90101: SOBERLINK Connect - 01
• B90107: SOBERLINK LTE REFURB- 07
• B90106: SOBERLINK LTE - 06
• B90109: SOBERLINK Connect ST REFURB
• B90108: SOBERLINK CONNECT ST - 08
• B90111: SOBERLINK CELLULAR CATM REFURB
• B90110: SOBERLINK CELLULAR CATM