FDA UDI
In Commercial Distribution
🇺🇸 United States
STERIS
DI: 00724995194208
·
Model: Patient Warming System
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STERIS
- Primary DI
- 00724995194208
- Version / Model
- Patient Warming System
- Catalog Number
- BF030
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 036985604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 3
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 531c85e4-38c2-47ac-957a-71e517d93961
Device Description
The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional overbody blanket immediately upon transfer to the surgical table to provide heat to the patient before, during or after procedures in the Operating Room.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 37329 | Electric pad whole-body heating system | An assembly of electrically-powered devices designed to heat a patient's whole body to compensate for the loss of normal body heat. The system includes a flat pad with electrical heating elements designed to be placed under or over the patient, and a control unit to regulate the heat; some types may be capable of monitoring the temperature at the patient’s body surface. The pad is available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). It is typically used in the operating room (OR), adult or neonatal intensive care unit (ICU), recovery units, or during neonatal transportation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995194208 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]