FDA UDI
In Commercial Distribution
🇺🇸 United States
Air Comfort
DI: 09343062029642
·
Model: AC59111
·
K CARE HEALTHCARE SOLUTIONS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Air Comfort
- Primary DI
- 09343062029642
- Version / Model
- AC59111
- Company Name
- K CARE HEALTHCARE SOLUTIONS PTY LTD
- Labeler DUNS
- 746978279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-13
- Public Version
- 1
- Public Version Date
- 2025-03-21
- Public Version Status
- New
- Public Device Record Key
- 26e937ec-2e71-4caf-a9d7-668815121e7f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| FRJ | Chair, Geriatric | General Hospital | 880.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10795 | Flotation therapy chair | A mains electricity (AC-powered) specialized device designed to support a patient in a seated position and minimize pressure points on the patient's body. This is achieved by creating chair contact with as much of the body surface as possible, typically through a series of inflated cushions that simultaneously lift the patient and simulate floating. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09343062029642 | GS1 |