FDA UDI
In Commercial Distribution
🇺🇸 United States
Vasomedical™ AngioNew -VI EECP® Therapy System
DI: 00817980020764
·
Model: Model AngioNew VI
·
VASOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vasomedical™ AngioNew -VI EECP® Therapy System
- Primary DI
- 00817980020764
- Version / Model
- Model AngioNew VI
- Catalog Number
- A12-0003
- Company Name
- VASOMEDICAL, INC.
- Labeler DUNS
- 197210248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a5a1624f-4a84-4aa5-9306-d7936b14e456
Device Description
System, AngioNew VI, 110V
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
- 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 |
|---|---|---|---|---|
| DRN | Device, counter-pulsating, external | Cardiovascular | 870.5225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61283 | External counterpulsation system, mobile | A noninvasive, mobile assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes an air pump with inflatable cuffs, ECG cables, a control unit or software for use with a personal computer (PC), and may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817980020764 | GS1 |
Customer Contacts
- Phone
- +1(516)508-5818
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033617 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity