FDA UDI
In Commercial Distribution
🇺🇸 United States
Aermos software
DI: 00856298006343
·
Model: 102400
·
ScottCare Cardiovascular Solutions
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aermos software
- Primary DI
- 00856298006343
- Version / Model
- 102400
- Company Name
- ScottCare Cardiovascular Solutions
- Labeler DUNS
- 116975567
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-28
- Public Version
- 1
- Public Version Date
- 2025-11-05
- Public Version Status
- New
- Public Device Record Key
- 32ff8429-84b4-4f8b-95e5-3ee779614860
Device Description
The TeleRehab® Aermos Cardiopulmonary Rehabilitation System (“Aermos”) provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44098 | Cardiology information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856298006343 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250259 | 000 |