FDA UDI
In Commercial Distribution
🇺🇸 United States
s-max
DI: 04054959000280
·
Model: D1611
·
AAT Alber Antriebstechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- s-max
- Primary DI
- 04054959000280
- Version / Model
- D1611
- Company Name
- AAT Alber Antriebstechnik GmbH
- Labeler DUNS
- 314612359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-19
- Public Version
- 1
- Public Version Date
- 2025-08-27
- Public Version Status
- New
- Public Device Record Key
- 5a164f73-8784-48ba-9396-5ee93de7af4a
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ILK | Transport, Patient, Powered | Physical Medicine | 890.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30039 | Stairclimber | A non-fixed mechanical device designed to transport a disabled or infirm person up or down stairs and can be controlled by an attendant/nursing staff, or the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04054959000280 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130864 | 000 |