FDA.reportPublic FDA data

ASSURE Wearable ECG

Primary DI
00840241600313
Brand
ASSURE Wearable ECG
Company
Kestra Medical Technologies, Inc.
Model
80553-001
Catalog number
80553-001
Device description
A wearable cardiac episode recorder
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233864000ASSURE Wearable ECGKestra Medical Technologies, Inc.2024-05-07MWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840241600313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840241600313008402416003138402416003130840241600313

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.833.692.7787xx@xx.xx

Regulatory Flags#

DUNS number
060944361
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840241600375ASSURE WCD System80014-00380014-0032026-04-15
00840241600405ASSURE, Monitor80008-00580008-0052026-04-15
00840241600412Kestra Provided Device Patient Application80740-01080740-0102026-02-04
00840241600399Kestra Provided Device Patient Application80740-00580740-0052025-04-30
00840241600382Kestra Provided Device Patient Application80740-00180740-0012024-09-18
00840241600320Battery 80499-00380499-0032024-09-18
00840241600337System Cable80500-00380500-0032024-09-18
00840241600344ASSURE Assist Service80739-00180739-0012024-09-18
00840241600238ASSURE WCD System80014-00280014-0022023-06-26
00840241600283ASSURE Patient Application80601-001 80601-001 2023-03-13
00840241600306CareStation Server80605-00480605-0042023-03-12
00840241600290CareStation Server80605-00380605-0032023-02-12
00840241600276CareStation Server80433-00380433-0032023-02-10
00840241600221ASSURE, Monitor80008-00480008-0042022-12-09
00840241600245ASSURE, Tablet80041-00280041-0022022-12-09
00840241600269CareStation Server80433-00280433-0022022-06-10
00840241600252ASSURE Patient Application80429-00380429-0032022-06-24
00840241600009ASSURE, Battery 3322882-0053322882-0052021-11-15
00840241600016ASSURE, Charger3326633-0043326633-0042021-11-15
00840241600023ASSURE, Therapy Cable80004-00380004-0032021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250903203381CardioMem getemed Medizin- und Informationstechnik AGMWJ2026-05-01
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.MWJ2025-12-17
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04