FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327487572
·
Model: HM34SPU-HLF-B
·
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327487572
- Version / Model
- HM34SPU-HLF-B
- Catalog Number
- HM34SPU-HLF-B
- Company Name
- STRYKER SUSTAINABILITY SOLUTIONS, INC.
- Labeler DUNS
- 020198912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-10
- Public Version
- 3
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- e1300ba9-f81c-40f8-bea7-be1b0cf71c06
Device Description
HoverMatt Half-Matt 34" W x 45" L
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
- Yes
- 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 |
|---|---|---|---|---|
| 66835 | Inflatable patient transfer sliding mattress, single-use | 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; some types may additionally be designed to provide skin protection to prevent pressure sores and/or support a patient in a specific position (e.g., Trendelenburg). 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 57613327487577 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 07613327487572 | GS1 | ||||
| Previous | 10817357022398 | GS1 |
Customer Contacts
- Phone
- +1(888)888-3433
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45.0 | Inch | |
| Width | 34.0 | Inch |