CardioSTAT
- Primary DI
- 17540279200140
- Brand
- CardioSTAT
- Company
- Icentia Inc.
- Model
- 10-006
- Device description
- CardioSTAT ECG Recorder 14D test.
- Published
- 2024-03-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DSH | Recorder, Magnetic Tape, Medical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DSH | Recorder, Magnetic Tape, Medical | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K223049 | 000 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023-03-22 | DSH |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 27540279200147 | Package | GS1 | 10 | In Commercial Distribution |
| 17540279200140 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 27540279200147 | 27540279200147 |
| 17540279200140 | 17540279200140 |
GMDN Terms
| Term | Definition |
|---|
| Electrocardiographic ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). |
Regulatory Flags
- DUNS number
- 241983607
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 17540279200027 | CardioSTAT | Icentia Inc. | DSH | 2025-12-08 |
| 27540279250029 | CardioSTAT | Icentia Inc. | DSH | 2024-12-18 |
| 27540279250074 | CardioSTAT | Icentia Inc. | DSH | 2024-12-18 |
| 27540279250142 | CardioSTAT | Icentia Inc. | DSH | 2024-12-18 |
| B146EP25R0 | ePatch Sensor 2.5, Rebuilt | BRAEMAR MANUFACTURING, LLC | DSH | 2024-06-26 |
| 04250413405640 | ABPM pro basic device | SOMNOmedics GmbH | DSH | 2024-05-08 |
| 00815187020112 | Matrix Wearable | GLOBAL INSTRUMENTATION, LLC | DSH | 2024-04-01 |
| 00815187020440 | Matrix Wearable | GLOBAL INSTRUMENTATION, LLC | DSH | 2024-04-01 |
| 00815187020457 | Matrix Wearable | GLOBAL INSTRUMENTATION, LLC | DSH | 2024-04-01 |
| 00815187020587 | Matrix Wearable | GLOBAL INSTRUMENTATION, LLC | DSH | 2024-04-01 |
| 00815187020594 | Matrix Wearable | GLOBAL INSTRUMENTATION, LLC | DSH | 2024-04-01 |
| 17540279105018 | EART | Icentia Inc. | DSH | 2024-03-26 |
| 17540279200072 | CardioSTAT | Icentia Inc. | DSH | 2024-03-26 |
| B322H0011 | LD-EKG | LD TECHNOLOGY, LLC | DSH | 2024-03-05 |
| 06944413820463 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | 2023-11-30 |
| 06944413820470 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | 2023-11-30 |
| 06944413820487 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | 2023-11-30 |
| 06944413820494 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | 2023-11-30 |
| 06944413820500 | Holter ECG and ABP System | Edan Instruments, Inc. | DSH | 2023-11-30 |
| B146EP2520 | ePatch 2.5, BTI | BRAEMAR MANUFACTURING, LLC | DSH | 2023-11-22 |
| 00812324000204 | GEMS Win Arrhythmia | CardioComm Solutions, Inc | DSH | 2023-11-09 |
| 00812324000211 | GEMS Win TTM | CardioComm Solutions, Inc | DSH | 2023-11-09 |
| 00812324000242 | GEMS Win AutoAttendant | CardioComm Solutions, Inc | DSH | 2023-11-09 |
| 00812324000259 | GEMS Win Air | CardioComm Solutions, Inc | DSH | 2023-11-09 |
| 00812324000228 | GEMS Win TTM & ICD | CardioComm Solutions, Inc | DSH | 2023-11-08 |
| 00812324000266 | GEMS Win HL7 | CardioComm Solutions, Inc | DSH | 2023-11-08 |
| 08800159500015 | S-Patch Ex | Wellysis Corp. | DSH | 2023-11-08 |
| B146EP2510 | ePatch 2.5, BTH | BRAEMAR MANUFACTURING, LLC | DSH | 2023-01-20 |
| 18800069700175 | AT-Patch | ATsens Co., Ltd. | DSH | 2022-12-23 |
| 00850043625001 | Strados Labs | Strados Labs, Inc. | DSH | 2022-12-02 |