FDA UDI
In Commercial Distribution
🇺🇸 United States
VitaHEAT UB3 Patient Warming System - Battery Power
DI: 00851446007104
·
Model: 7003-A
·
VITA HEAT MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VitaHEAT UB3 Patient Warming System - Battery Power
- Primary DI
- 00851446007104
- Version / Model
- 7003-A
- Company Name
- VITA HEAT MEDICAL
- Labeler DUNS
- 021249224
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ae38fcc5-0942-453a-9261-7324c5625acc
Device Description
The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 2002 Controller, QTY 2 Model 100026 Batteries, and a Model 3001-C Battery Charger.
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
- 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 |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37329 | Electric pad whole-body heating system | An assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851446007104 | GS1 |
Customer Contacts
- Phone
- 800.850.8350
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132454 | 000 |