FDA UDI
In Commercial Distribution
🇺🇸 United States
Maxi-Therm Lite
DI: 20613031838760
·
Model: 876-USME
·
Gentherm Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Maxi-Therm Lite
- Primary DI
- 20613031838760
- Version / Model
- 876-USME
- Catalog Number
- 876-USME
- Company Name
- Gentherm Medical, LLC
- Labeler DUNS
- 004249462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-05-13
- Public Version
- 1
- Public Version Date
- 2024-05-21
- Public Version Status
- New
- Public Device Record Key
- 6382be24-361c-4ec1-87e6-117e68f3feb1
Device Description
Thermal Regulation Pad
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 61251 | External circulating-fluid core temperature regulation system pad, single-use | 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, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10613031838763 | GS1 | ||||
| Primary | 20613031838760 | GS1 |
Customer Contacts
- Phone
- 8009897373
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 64 | Inch | |
| Width | 25 | Inch | |
| Weight | 9.34 | Pound |