FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04260498580002
·
Model: TECOTHERM NEO
·
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04260498580002
- Version / Model
- TECOTHERM NEO
- Company Name
- TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
- Labeler DUNS
- 315496666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- c0172f10-1b3f-4bb6-b926-b1f3d7aca60d
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 |
|---|---|---|---|---|
| 36956 | External circulating-fluid core temperature regulation system control unit, heating/cooling | An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260498580002 | GS1 |