FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10885380168529
·
Model: ST-HM50SPU-B
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380168529
- Version / Model
- ST-HM50SPU-B
- Catalog Number
- ST-HM50SPU-B
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-03
- Public Version
- 2
- Public Version Date
- 2025-02-13
- Public Version Status
- Update
- Public Device Record Key
- fe706f9f-46c2-413f-94dd-f43894152535
Device Description
Hovertech Hovermatt Lateral 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
- No
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 | 50885380168527 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 10885380168529 | GS1 |