FDA.reportPublic FDA data

Cardioskin Battery

Primary DI
03615220001149
Brand
Cardioskin Battery
Company
BIOSERENITY MEDICAL DEVICES GROUP
Model
1005-15002-US
Catalog number
1005-15002-US
Published
2019-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173248000CARDIOSKINBioserenity Sas2018-08-11DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615220001149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615220001149036152200011493615220001149

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
281224773
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615220004355Neuronaute IceCap 2 Small1001-01026-UN2026-03-17
03615220004331Neuronaute IceCap 21001-01025-UN2025-11-28
03615220003846Neuronaute Touchproof Adapter1001-15024-UN1001-15024-US2025-04-17
03615220003471Neuronaute - IceAdapter1001-15020-US2023-01-12
03615220003617Neuronaute IceCap 21001-01014-UN2023-01-25
03615220003624Neuronaute - IceAdapter1001-15020-UN2025-04-18
03615220003792Neuronaute IceCap 2 Small 1001-01015-UN2023-01-25
03615220004171Neuronaute Touchproof Adapter1001-15024-US1001-15024-US2023-04-24
03615220003952Neuronaute® IceCap Neonate (M)1001-01018-UN2025-04-17
03615220003969Neuronaute® IceCap Neonate (S)1001-01019-UN2025-04-17
03615220003976Neuronaute® IceCap Neonate (XS)1001-01020-UN2025-04-17
03615220003679Neuronaute Plus Touchproof Extender1001-15023-UN2024-05-22
03615220003983Neuronaute Plus- Holding Band1001-05001-UN2024-03-21
03615220003655Neuronaute Plus - DB25 Extender1001-15021-UN2024-02-20
03615220003662Neuronaute Plus- IceCap Extender1001-15022-UN2024-02-20
03615220003990Neuronaute Plus - Core Module 1001-10006-US2024-02-20
03615220004294Neuronaute Mobile Application Android5100-000242024-02-20
03615220001729Neuronaute 1.2 - High capacity battery module1001-15016-UN2023-01-12
03615220001781Neuronaute 1.2 - BioAdapter1001-15015-US2023-01-12
03615220001798Neuronaute 1.2 - Battery charger1001-15017-US2023-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23