Mistral-Air
- Primary DI
- 18719867001035
- Brand
- Mistral-Air
- Company
- The Surgical Company International B.V.
- Model
- MA2450
- Device description
- Mistral-Air® Half Underbody Plus
- Published
- 2025-01-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DWJ | System, Thermal Regulating |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 18719867001035 | Package | GS1 | 40 | In Commercial Distribution |
| 18719867001028 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 18719867001035 | 18719867001035 |
| 18719867001028 | 18719867001028 |
GMDN Terms
| Term | Definition |
|---|---|
| External circulating-air core temperature regulation system pad, single-use | An underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 409656493
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08719867002769 | Fluido® AirGuard System | 671500-US | 2025-09-12 | |
| 08719867002790 | Fluido® AirGuard System | 651115-US | 2025-09-12 | |
| 18719867001615 | Fluido® AirGuard System | 660200A | 2025-09-12 | |
| 18719867001622 | Fluido® AirGuard System | 660300 | 2025-09-12 | |
| 18719867001646 | Fluido® AirGuard System | 661400 | 2025-09-12 | |
| 18719867001653 | Fluido® AirGuard System | 660500-B | 2025-09-12 | |
| 18719867002254 | Fluido® AirGuard System | 671200-US | 2025-09-12 | |
| 18719867002636 | Mistral-Air | MA2455 | 2025-01-30 | |
| 18719867002650 | Mistral-Air | MA3455 | 2025-01-30 | |
| 18719867000076 | Mistral-Air | MA1200-US | 2025-01-30 | |
| 18719867000212 | Mistral-Air | MA0510 | 2025-01-30 | |
| 18719867000540 | Mistral-Air | MA2220 | 2025-01-30 | |
| 18719867000595 | Mistral-Air | MA2230 | 2025-01-30 | |
| 18719867000632 | Mistral-Air | MA2240 | 2025-01-30 | |
| 18719867000663 | Mistral-Air | MA2250 | 2025-01-30 | |
| 18719867000717 | Mistral-Air | MA2260 | 2025-01-30 | |
| 18719867000755 | Mistral-Air | MA2265 | 2025-01-30 | |
| 18719867000793 | Mistral-Air | MA2270 | 2025-01-30 | |
| 18719867002056 | Mistral-Air | MA2280 | 2025-01-30 | |
| 18719867002063 | Mistral-Air | MA2285 | 2025-01-30 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 19332017004138 | Cocoon | CARE ESSENTIALS PTY LTD | DWJ | 2026-02-25 |
| 19332017004152 | Cocoon | CARE ESSENTIALS PTY LTD | DWJ | 2026-02-25 |
| 00197998154973 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998154997 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155017 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155031 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155055 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155079 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155093 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
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| 00197998155871 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155895 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155918 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155932 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155956 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155970 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998155994 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998156014 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998156038 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998156373 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998156397 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998156410 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998158469 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998158490 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00197998318184 | Solventum™ Bair Hugger™ | Solventum US LLC | DWJ | 2026-01-30 |
| 00614801000062 | Medical Warming Systems | R.G. ENTERPRISES (U.S.A.), INC. | DWJ | 2025-07-09 |
| 00614801000079 | Medical Warming Systems | R.G. ENTERPRISES (U.S.A.), INC. | DWJ | 2025-07-09 |
| 00614801000086 | Medical Warming Systems | R.G. ENTERPRISES (U.S.A.), INC. | DWJ | 2025-07-09 |
| 20197344129079 | MEDLINE | MEDLINE INDUSTRIES, INC. | DWJ | 2025-05-07 |
| 20197344129086 | MEDLINE | MEDLINE INDUSTRIES, INC. | DWJ | 2025-05-07 |