FDA UDI
In Commercial Distribution
🇺🇸 United States
Sustainable Technologies
DI: 10885380203138
·
Model: ST-RGMT39HLF-REG
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sustainable Technologies
- Primary DI
- 10885380203138
- Version / Model
- ST-RGMT39HLF-REG
- Catalog Number
- ST-RGMT39HLF-REG
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-10
- Public Version
- 1
- Public Version Date
- 2025-09-18
- Public Version Status
- New
- Public Device Record Key
- 3a74af0d-733b-4c70-85d7-e39f63227a6e
Device Description
Regard HoverMatt® SPU Air Transfer Mattress
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRZ | DEVICE, PATIENT TRANSFER, POWERED | General Hospital | 880.6775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66401 | Inflatable patient transfer sliding mattress, reprocessed | An inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques. It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380203136 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10885380203138 | GS1 |