FDA UDI
In Commercial Distribution
🇺🇸 United States
Sittan
DI: 04527799700110
·
Model: KF-890U
·
PARAMOUNT BED CO., LTD.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sittan
- Primary DI
- 04527799700110
- Version / Model
- KF-890U
- Company Name
- PARAMOUNT BED CO., LTD.
- Labeler DUNS
- 690552500
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-10
- Public Version
- 1
- Public Version Date
- 2020-01-20
- Public Version Status
- New
- Public Device Record Key
- 8e698510-fb2e-4b78-8be3-e7d20a41c26a
Device Description
Mechanical table to support a patient with the right position
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
- No
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
| INW | Table, Mechanical | Physical Medicine | 890.3750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35395 | Overbed table | A table designed to be moved directly over the bed of a patient/occupant to provide them with a surface to eat, read, or write while in bed. It is typically constructed as a C-shaped metal framework with a table top surface, on which objects are placed, and small Castor wheels to provide the mobility for moving it over the bed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04527799700110 | GS1 |