FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Warming Mattress
DI: 00851446007005
·
Model: 4003
·
VITA HEAT MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Patient Warming Mattress
- Primary DI
- 00851446007005
- Version / Model
- 4003
- 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
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 43690373-6626-4eb2-adea-42ce2d3d8eb3
Device Description
The Model 4003 Patient Warming Mattress is an electrical patient warming mattress that is connected to a Model 2002 Controller and is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Patient Warming Mattress provides warmth for a patient.
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 |
|---|---|---|---|---|
| 11989 | External electric-heating core temperature regulation system pad | An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851446007005 | GS1 |
Customer Contacts
- Phone
- 800.850.8350
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132454 | 000 |