FDA UDI
In Commercial Distribution
🇺🇸 United States
CER-S
DI: B972CCZ12050482030
·
Model: 4
·
CARDIO CALM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CER-S
- Primary DI
- B972CCZ12050482030
- Version / Model
- 4
- Company Name
- CARDIO CALM SRL
- Labeler DUNS
- 431076243
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 1
- Public Version Date
- 2021-01-08
- Public Version Status
- New
- Public Device Record Key
- 51259e02-0ddd-458e-a93d-a2f81b63bec3
Device Description
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41651 | Electrocardiographic long-term ambulatory recording analyser application software | A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B972CCZ12050482030 | HIBCC |
Customer Contacts
- Phone
- +39 0308140128
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193177 | 000 |