Steth IO

GUDID 00860135001934

Steth IO - The Smartphone Stethoscope for iPhone X

Steth IO

Electronic stethoscope

• Primary Device ID: 00860135001934
• NIH Device Record Key: c3c169c1-f79e-4e02-9e0f-55d224f9757f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steth IO
• Version Model Number: iPhone X
• Company DUNS: 079694124
• Company Name: Steth IO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860135001934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160016

FDA Product Code

• DQD: Stethoscope, Electronic

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: 2018-07-09
• Device Publish Date: 2018-06-06

On-Brand Devices [Steth IO]

• 00860135001934: Steth IO - The Smartphone Stethoscope for iPhone X
• 00860135001927: Steth IO - The Smartphone Stethoscope for iPhone 7+ or 8+
• 00860135001910: Steth IO - The Smartphone Stethoscope for iPhone 7 or 8
• 00860135001903: Steth IO - The Smartphone Stethoscope for iPhone 6