FDA UDI
In Commercial Distribution
🇺🇸 United States
Mistral-Air
DI: ET37MA2285PM0
·
Model: MA2285-PM
·
The Surgical Company International B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mistral-Air
- Primary DI
- ET37MA2285PM0
- Version / Model
- MA2285-PM
- Company Name
- The Surgical Company International B.V.
- Labeler DUNS
- 409656493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 3
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- aa49ff12-cd3e-4122-b7b1-4a0ce4529bb2
Device Description
Mistral-Air Blanket, Lower Surgical Access Plus (sterile) - SYK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47682 | Circulating-air whole-body heating/cooling system pad, single-use, sterile | A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ET37MA2285PM0 | HIBCC | ||||
| Package | ET37MA2285PM1 | HIBCC | box | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101705 | 000 |