Home GUDID 03615220001033 Cardioskin Textile S22
Primary DI 03615220001033
Brand Cardioskin Textile S22
Company BIOSERENITY MEDICAL DEVICES GROUP
Model 1005-00001-US
Catalog number 1005-00001-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 Code Name DRX Electrode, Electrocardiograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRX Electrode, Electrocardiograph Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03615220001033 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03615220001033 03615220001033 3615220001033
GMDN Terms# Term, Definition table Term Definition Electrocardiography telemetric monitoring system An 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 Type Low High Condition Storage Environment Atmospheric Pressure 700 KiloPascal 1060 KiloPascal Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 35 Degrees Celsius
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 DI Brand Model Catalog Published 03615220004355 Neuronaute IceCap 2 Small 1001-01026-UN 2026-03-17 03615220004331 Neuronaute IceCap 2 1001-01025-UN 2025-11-28 03615220003846 Neuronaute Touchproof Adapter 1001-15024-UN 1001-15024-US 2025-04-17 03615220003471 Neuronaute - IceAdapter 1001-15020-US 2023-01-12 03615220003617 Neuronaute IceCap 2 1001-01014-UN 2023-01-25 03615220003624 Neuronaute - IceAdapter 1001-15020-UN 2025-04-18 03615220003792 Neuronaute IceCap 2 Small 1001-01015-UN 2023-01-25 03615220004171 Neuronaute Touchproof Adapter 1001-15024-US 1001-15024-US 2023-04-24 03615220003952 Neuronaute® IceCap Neonate (M) 1001-01018-UN 2025-04-17 03615220003969 Neuronaute® IceCap Neonate (S) 1001-01019-UN 2025-04-17 03615220003976 Neuronaute® IceCap Neonate (XS) 1001-01020-UN 2025-04-17 03615220003679 Neuronaute Plus Touchproof Extender 1001-15023-UN 2024-05-22 03615220003983 Neuronaute Plus- Holding Band 1001-05001-UN 2024-03-21 03615220003655 Neuronaute Plus - DB25 Extender 1001-15021-UN 2024-02-20 03615220003662 Neuronaute Plus- IceCap Extender 1001-15022-UN 2024-02-20 03615220003990 Neuronaute Plus - Core Module 1001-10006-US 2024-02-20 03615220004294 Neuronaute Mobile Application Android 5100-00024 2024-02-20 03615220001729 Neuronaute 1.2 - High capacity battery module 1001-15016-UN 2023-01-12 03615220001781 Neuronaute 1.2 - BioAdapter 1001-15015-US 2023-01-12 03615220001798 Neuronaute 1.2 - Battery charger 1001-15017-US 2023-01-12
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