FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Viterion 100 TeleHealth Monitor
DI: 00852579007009
·
Model: 3.5.0.en
·
VITERION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Viterion 100 TeleHealth Monitor
- Primary DI
- 00852579007009
- Version / Model
- 3.5.0.en
- Catalog Number
- 81842478
- Company Name
- VITERION CORPORATION
- Labeler DUNS
- 078831113
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 567c55ea-15c6-4a5a-ae49-afefe718c128
- Distribution End Date
- 2016-12-12
Device Description
A convenient, easy-to-use, tabletop physiological monitoring system.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18118 | Home healthcare information system | A dedicated assembly of devices designed 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 home healthcare services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852579007009 | GS1 | ||||
| Package | 10852579007006 | GS1 | Inner Pack (sleeve) | 5 | Not in Commercial Distribution | 2016-12-12 |
Customer Contacts
- Phone
- 8008660133
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 3.800 | Pound | |
| Depth | 3.900 | Inch | |
| Width | 9.720 | Inch | |
| Height | 7.680 | Inch |