Mistral-Air
GUDID 18719867002087
Mistral-Air Blanket, Surgical Access Plus (sterile) - SYK
The Surgical Company International B.V.
Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use, sterile Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use Circulating-air whole-body heating/cooling system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use External circulating-air core temperature regulation system pad, single-use| Primary Device ID | 18719867002087 |
| NIH Device Record Key | 4e65791b-da89-4037-8c5d-b132fe90f70f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mistral-Air |
| Version Model Number | MA2280-PM |
| Company DUNS | 409656493 |
| Company Name | The Surgical Company International B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18719867000847 [Primary] |
| GS1 | 18719867000854 [Package] Package: BOX [2 Units] In Commercial Distribution |
| GS1 | 18719867002087 [Package] Contains: 18719867000847 Package: BOX [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101705
FDA Product Code
| DWJ | System, Thermal Regulating |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-27 |
| Device Publish Date | 2022-05-19 |
On-Brand Devices [Mistral-Air]
| ET375250PM0 | MA1200 Trolley - SYK |
| ET37MA3450PM0 | Mistral-Air® Premium Half Underbody - SYK |
| ET37MA3400PM0 | Mistral-Air® Premium Full Underbody - SYK |
| ET37MA3365PM1 | Mistral-Air® Premium Half Upper Body - SYK |
| ET37MA3360PM1 | Mistral-Air® Premium Upper Body - SYK |
| ET37MA3350PM1 | Mistral-Air® Premium Lower Body - SYK |
| ET37MA3340PM1 | Mistral-Air® Premium Neonatal - SYK |
| ET37MA3330PM1 | Mistral-Air® Premium Paediatric - SYK |
| ET37MA2475PM0 | Mistral-Air® Paediatric Underbody Plus - SYK |
| ET37MA2450PM0 | Mistral-Air® Half Underbody Plus – SYK |
| ET37MA2400PM0 | Mistral-Air® Full Underbody Plus – SYK |
| ET37MA2290PM0 | Mistral-Air® Blanket, Surgical Access Plus - SYK |
| ET37MA2286PM0 | Mistral-Air Blanket, Cardiac Blanket Plus (sterile) - SYK |
| ET37MA2285PM0 | Mistral-Air Blanket, Lower Surgical Access Plus (sterile) - SYK |
| ET37MA2280PM0 | Mistral-Air Blanket, Surgical Access Plus (sterile) - SYK |
| ET37MA2270PM0 | Mistral-Air® Torso Plus - SYK |
| ET37MA2265PM0 | Mistral-Air® Half Upper Body Plus – SYK |
| ET37MA2260PM0 | Mistral-Air® Upper Body Plus – SYK |
| ET37MA2250PM0 | Mistral-Air® Lower Body Plus – SYK |
| ET37MA2240PM0 | Mistral-Air® Neonatal Plus – SYK |
| ET37MA2230PM0 | Mistral-Air® Paediatric Plus – SYK |
| ET37MA2220PM0 | Mistral-Air® Adult Plus – SYK |
| ET37MA1740PM0 | Mistral-Air® Warming Suit, XL - SYK |
| ET37MA1730PM0 | Mistral-Air® Warming Suit, L - SYK |
| ET37MA1720PM0 | Mistral-Air® Warming Suit, M/L - SYK |
| ET37MA1710PM0 | Mistral-Air® Warming Suit, S – SYK |
| ET37MA1640PM0 | Mistral-Air® Premium Warming Suit, X Large - SYK |
| ET37MA1630PM0 | Mistral-Air® Premium Warming Suit, Large - SYK |
| ET37MA1620PM0 | Mistral-Air® Premium Warming Suit, Medium - SYK |
| ET37MA1610PM0 | Mistral-Air® Premium Warming Suit, Small - SYK |
| ET37MA1200PM0 | Mistral-Air® Warming Unit - SYK |
| ET37MA1100PM0 | Mistral-Air® Plus Warming Unit - SYK (110-120V) |
| ET37MA0510PM0 | Mistral-Air® Tube - SYK |
| ET37MA0450PM0 | Mistral-Air® Underbody Reflective - SYK |
| ET37MA0400PM0 | Mistral-Air® Full Underbody Reflective - SYK |
| ET37MA0365PM0 | Mistral-Air® Half Upper Body Reflective - SYK |
| ET37MA0360PM0 | Mistral-Air® Upper Body Reflective - SYK |
| ET37MA0350PM0 | Mistral-Air® Lower Body Reflective - SYK |
| ET37MA0340PM0 | Mistral-Air® Neonatal Reflective - SYK |
| ET37MA0330PM0 | Mistral-Air® Paediatric Reflective - SYK |
| ET37MA0320PM0 | Mistral-Air® Adult Reflective - SYK |
| ET37MA02010PM0 | Mistral-Air® Faceshield – SYK |
| 18719867001547 | Mistral-Air® Adjustable Pole - SYK |
| 18719867001400 | Mistral-Air® Premium Half Underbody - SYK |
| 18719867001370 | Mistral-Air® Premium Full Underbody - SYK |
| 18719867001332 | Mistral-Air® Premium Half Upper Body - SYK |
| 18719867001295 | Mistral-Air® Premium Upper Body - SYK |
| 18719867001240 | Mistral-Air® Premium Lower Body - SYK |
| 18719867001219 | Mistral-Air® Premium Neonatal - SYK |
| 18719867001172 | Mistral-Air® Premium Paediatric - SYK |
Trademark Results [Mistral-Air]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MISTRAL-AIR 85186399 4008906 Live/Registered |
The Surgical Company International B.V. 2010-11-29 |
 MISTRAL-AIR 79062248 not registered Dead/Abandoned |
The Surgical Company International B.V. 2008-09-19 |
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