Strados Labs

Basic Information

• Brand Name: Strados Labs
• Primary DI: 00850043625018
• Version / Model: SWD1
• Catalog Number: 810-00007
• Company Name: Strados Labs, Inc.
• Labeler DUNS: 080427352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 36c9d074-7cdc-4a90-9040-b7a23b43ea3c

Device Description

Wearable Device, SWD1, Boxed & Labeled

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62276	Cough ambulatory recording system	An assembly of devices intended for 24-hour detection and recording of the number of times a patient coughs during daily activities or sleep, typically in the assessment of patients affected by various disorders associated with coughing (e.g., asthma, COPD). It typically consists of body-worn microphones and acoustic sensors designed to detect coughing sounds, and a small battery-powered portable recorder for registering the data. The recorded data is typically downloaded for analysis at a medical facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850043625018	GS1