FDA UDI
In Commercial Distribution
🇺🇸 United States
Soft Air
DI: 10615089191302
·
Model: A285
·
ADROIT MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Soft Air
- Primary DI
- 10615089191302
- Version / Model
- A285
- Catalog Number
- 1913-0001
- Company Name
- ADROIT MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 795104769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-15
- Public Version
- 4
- Public Version Date
- 2019-08-06
- Public Version Status
- Update
- Public Device Record Key
- ecebbed5-c188-4874-878e-622a05ec61ee
Device Description
Blanket, Lower Surgical Access, White
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36954 | Circulating-air whole-body heating system control unit | A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20615089191309 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 10615089191302 | GS1 |
Customer Contacts
- Phone
- 865-458-8600
- [email protected]