FDA UDI
In Commercial Distribution
🇺🇸 United States
Adjustable mattress
DI: 06973852590101
·
Model: H003, H101, H104, H009, H102, H105, H010, H103, H106
·
Kunshan Hi-Fortune Health Products Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Adjustable mattress
- Primary DI
- 06973852590101
- Version / Model
- H003, H101, H104, H009, H102, H105, H010, H103, H106
- Company Name
- Kunshan Hi-Fortune Health Products Co.,Ltd
- Labeler DUNS
- 548310008
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- 1a6f119f-2af2-476a-bca0-154c39c9c304
Device Description
Adjustable mattress, Model: H003, H101, H104, H009, H102, H105, H010, H103, H106.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32153 | Bed mattress support platform, electric | A mains electricity (AC-powered) medical bed structure that supports a medical bed patient surface (e.g., a mattress) and that can articulate and/or change its surface to facilitate various therapeutic, diagnostic, and convenience positions. It is typically a flat structure made of a metal frame that operates in response to an electrically-operated bed control device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973852590101 | GS1 |