FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cherish Serenity
DI: B353CS124501
·
Model: CS1245
·
Lifesignals, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Cherish Serenity
- Primary DI
- B353CS124501
- Version / Model
- CS1245
- Company Name
- Lifesignals, Inc.
- Labeler DUNS
- 798830720
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 3
- Public Version Date
- 2022-04-13
- Public Version Status
- Update
- Public Device Record Key
- 48846381-64eb-45da-ac68-09f3e4424939
- Distribution End Date
- 2021-01-31
Device Description
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31733 | 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). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B353CS124502 | HIBCC | BOX | 25 | Not in Commercial Distribution | 2021-01-31 |
| Primary | B353CS124501 | HIBCC | ||||
| Package | B353CS124503 | HIBCC | Large Box | 8 | Not in Commercial Distribution | 2021-01-31 |
Customer Contacts
- Phone
- 510.770.6412
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172011 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius