FDA UDI
In Commercial Distribution
🇺🇸 United States
SKIN IQ 365
DI: 05055982783231
·
Model: SIQFNRU04UN
·
Arjohuntleigh AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SKIN IQ 365
- Primary DI
- 05055982783231
- Version / Model
- SIQFNRU04UN
- Company Name
- Arjohuntleigh AB
- Labeler DUNS
- 355804758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 02744c1b-3d29-470e-a11c-ac35c57189f0
Device Description
SKIN IQ 365, FAN KIT - 4 UNITS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IOQ | BED, FLOTATION THERAPY, POWERED | Physical Medicine | 890.5170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47652 | External circulating-air core temperature regulation system control unit, heating/cooling | An electrically-powered device intended to be used as part of an external circulating-air core temperature regulation system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a filter, an air heating and cooling mechanism 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 |
|---|---|---|---|---|---|---|
| Primary | 05055982783231 | GS1 |