FDA UDI
In Commercial Distribution
🇺🇸 United States
Hot Dog Trendelenburg Warming Mattress, 89 cm (35in)
DI: 00855913001985
·
Model: U300
·
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hot Dog Trendelenburg Warming Mattress, 89 cm (35in)
- Primary DI
- 00855913001985
- Version / Model
- U300
- Catalog Number
- U300
- Company Name
- AUGUSTINE TEMPERATURE MANAGEMENT LLC
- Labeler DUNS
- 965879187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 87450c5b-78fd-40fe-97f3-6e89e2c948ad
Device Description
Labeled: Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) U300
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
- 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 |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37329 | Electric pad whole-body heating system | An assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855913001985 | GS1 |
Customer Contacts
- Phone
- 952-746-1720
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092807 | 000 |