FDA UDI
In Commercial Distribution
🇺🇸 United States
AQUARI IMMERSION CONTROLLER REFURB
DI: 00842430116322
·
Model: 246AQIR
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AQUARI IMMERSION CONTROLLER REFURB
- Primary DI
- 00842430116322
- Version / Model
- 246AQIR
- Catalog Number
- 246AQIR
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-07
- Public Version
- 2
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- b56ef3b1-f56b-4071-82d0-d195ea689b32
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 | 00842430116322 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit