FDA UDI
In Commercial Distribution
🇺🇸 United States
TCmatt
DI: 04260647540031
·
Model: NEOmulti
·
Tec Com Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TCmatt
- Primary DI
- 04260647540031
- Version / Model
- NEOmulti
- Catalog Number
- 6426801
- Company Name
- Tec Com Medizintechnik GmbH
- Labeler DUNS
- 315215424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-18
- Public Version
- 1
- Public Version Date
- 2024-04-26
- Public Version Status
- New
- Public Device Record Key
- f47f1f92-5b84-4efe-bce4-ff70a6f87126
Device Description
Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOH | Mattress, Water, Temperature Regulated | General Hospital | 880.5560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36854 | External circulating-fluid core temperature regulation system pad, reusable | An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260647540031 | GS1 |
Customer Contacts
- Phone
- +493451205204
- [email protected]