FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioTouch3000
DI: 08809276943545
·
Model: CardioTouch3000
·
Bionet CO,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CardioTouch3000
- Primary DI
- 08809276943545
- Version / Model
- CardioTouch3000
- Company Name
- Bionet CO,LTD
- Labeler DUNS
- 689708212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-15
- Public Version
- 1
- Public Version Date
- 2021-07-23
- Public Version Status
- New
- Public Device Record Key
- d5c17a4e-6805-4f61-bc88-47554ee071a8
Device Description
System, ecg analysis
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34115 | ST-segment electrocardiographic monitor | A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG), and provide analysis of the ECG's ST segment, through leads and sensors attached to the patient; it may also measure and display other physiological parameters. ST-segment analysis may facilitate ischemia detection. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809276943542 | GS1 | Box | 4 | In Commercial Distribution | |
| Primary | 08809276943545 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023034 | 000 |