FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Wave HX, Hercules Mattress System
DI: 00819552022473
·
Model: Revision B
·
MOREL COMPANY, LLC., THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Wave HX, Hercules Mattress System
- Primary DI
- 00819552022473
- Version / Model
- Revision B
- Company Name
- MOREL COMPANY, LLC., THE
- Labeler DUNS
- 079202952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- 658560e6-6a0d-410c-a6b6-ed8e3d4943ca
- Distribution End Date
- 2036-04-01
Device Description
Hercules Patient Repositioning Device with Advanced Wave HX Controller and Mattress - Pneumatic, Revision B, 35" Width, 84" Length
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34870 | Basic electric hospital bed | A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819552022473 | GS1 |
Customer Contacts
- Phone
- 812-932-6100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 84 | Inch | |
| Width | 35 | Inch |