FDA.reportPublic FDA data

ANNE Chest Adhesive - Gentle Wear Shelf Box

Primary DI
00850064210309
Brand
ANNE Chest Adhesive - Gentle Wear Shelf Box
Company
Sibel Health Inc.
Model
900-00072
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLContinuous Measurement Thermometer
KMIMonitor, Bed Patient
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
KMIMonitor, Bed PatientGeneral Hospital1
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240251000ANNE ChestSibel Health, Inc.2024-06-03DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064210309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064210309008500642103098500642103090850064210309

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093772547
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064210286ANNE Link Mobile900-000692025-12-11
00850064210200Sibel Spacelabs Trek Chest Patch900-000392025-04-02
00850064210217Sibel Spacelabs Trek Finger Patch900-000412025-04-02
00850064210224Sibel Spacelabs Trek Charger900-000462025-04-02
00850064210231Sibel Spacelabs Finger Patch Adhesive 3 day900-000422025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch Adhesive900-000622025-04-02
00850064210255Sibel Spacelabs Trek Blood Pressure Cuff900-000452025-04-02
00850064210262Sibel Spacelabs Trek Tablet900-000432025-04-02
00860004541745ANNE Chest810-000122025-04-02
00860004541752ANNE Limb810-000132025-04-02
00850064210125ANNE Limb Adhesive Shelf Box900-000112025-03-27
00850064210163Central Hub CMS900-000132025-03-27
00850064210194Central Hub Speaker900-000042025-03-27
00850064210002ANNE Chest Sensor Kit900-000072025-03-26
008500642100197-Day ANNE Chest Adhesive Pouch900-000382025-03-26
008500642100261-Day ANNE Chest Adhesive Pouch900-000142025-03-26
00850064210057ANNE Bedside Wireless Charger900-000082025-03-26
00850064210088ANNE Limb Sensor Kit900-000032025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf Box900-000102025-03-26
00850064210132ANNE View Patient Monitor 900-000122025-03-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
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06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
07613327694819VisionSTRYKER CORPORATIONKMI2026-06-22
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00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.BZQ2026-06-03
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02