FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AQUARI SURF BACK STERIS 4085 5085
DI: 00842430115523
·
Model: 246-B4085
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AQUARI SURF BACK STERIS 4085 5085
- Primary DI
- 00842430115523
- Version / Model
- 246-B4085
- Catalog Number
- 246-B4085
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-04
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 75531989-ade1-4aba-8857-76f635575aa2
- Distribution End Date
- 2024-01-26
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
- 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
- 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 |
|---|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65167 | Operating table patient pressure distribution monitoring/regulation system | An assembly of devices designed to monitor and regulate a patient’s body pressure distribution on an operating table mattress to reduce the risk of soft tissue strain and pressure injuries during a surgical procedure. The device consists of: 1) a pressure-sensing mattress which detects surface pressure distribution and feedbacks this information to; 2) an electrically-powered control/pump unit designed to analyse the patient’s volumetric shape variations and inflate/deflate the mattress accordingly. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430115523 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity