Strados Labs 810-00007

GUDID 00850043625018

Wearable Device, SWD1, Boxed & Labeled

Strados Labs, Inc.

Cough ambulatory recording system

• Primary Device ID: 00850043625018
• NIH Device Record Key: 36c9d074-7cdc-4a90-9040-b7a23b43ea3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strados Labs
• Version Model Number: SWD1
• Catalog Number: 810-00007
• Company DUNS: 080427352
• Company Name: Strados Labs, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043625018 [Primary]

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [Strados Labs]

• 00850043625025: Charging Station, SCS1, Boxed & Labeled. This is a medical device accessory to the Strados Weara
• 00850043625018: Wearable Device, SWD1, Boxed & Labeled
• 00850043625001: Patient Adhesive, SPA1, Pack of 25. The SPA1 is a medical device accessory to the Strados Wearab