FDA.reportPublic FDA data

Strados Labs

Primary DI
00850043625018
Brand
Strados Labs
Company
Strados Labs, Inc.
Model
SWD1
Catalog number
810-00007
Device description
Wearable Device, SWD1, Boxed & Labeled
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043625018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043625018008500436250188500436250180850043625018

GMDN Terms#

Term, Definition table
TermDefinition
Cough ambulatory recording systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080427352
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043625001Strados LabsSPA1810-000192022-12-02
00850043625025Strados LabsSCS1810-000092022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
00884838123717Care AssistPhilips Medical Systems HsgDSH2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSH2024-11-27
00860007323409Vitals360Vocare, Inc.DSH2024-09-10
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLCDSH2024-06-26
04250413405640ABPM pro basic deviceSOMNOmedics AGDSH2024-05-08
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
17540279105018EARTIcentia Inc.DSH2024-03-26
17540279200072CardioSTATIcentia Inc.DSH2024-03-26