FDA UDI
In Commercial Distribution
🇺🇸 United States
WarmAir® 135
DI: 10613031861860
·
Model: 135
·
Gentherm Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WarmAir® 135
- Primary DI
- 10613031861860
- Version / Model
- 135
- Catalog Number
- 86186
- Company Name
- Gentherm Medical, LLC
- Labeler DUNS
- 004249462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 3
- Public Version Date
- 2021-09-23
- Public Version Status
- Update
- Public Device Record Key
- cba8f466-f8f2-4d19-b285-dbd45ecac690
Device Description
Convective Warming System
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 |
|---|---|---|---|---|
| 36954 | Circulating-air whole-body heating system control unit | A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10613031861860 | GS1 |
Customer Contacts
- Phone
- 1-800-989-7373
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6.1 | Kilogram | |
| Weight | 13.5 | Pound | |
| Height | 34.29 | Centimeter | |
| Depth | 22.2 | Centimeter | |
| Width | 22.2 | Centimeter | |
| Height | 13.5 | Inch | |
| Depth | 8.75 | Inch | |
| Width | 8.75 | Inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius