FDA UDI
In Commercial Distribution
🇺🇸 United States
Medibios
DI: G0602034S0
·
Model: plus
·
Amil Care Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medibios
- Primary DI
- G0602034S0
- Version / Model
- plus
- Catalog Number
- 2034.s
- Company Name
- Amil Care Corp.
- Labeler DUNS
- 082275360
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-04
- Public Version
- 1
- Public Version Date
- 2023-12-12
- Public Version Status
- New
- Public Device Record Key
- dd3d55f9-3210-46de-b817-c4c1e6cc53cd
Device Description
Diffuser of ready-to-use liquid solutions
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 |
|---|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58215 | Airborne device-disinfectant diffuser | A mains electricity (AC-powered) mobile device designed for the automated dispersion of an appropriate disinfectant [e.g., formaldehyde, hydrogen peroxide (H2O2)] into the atmosphere of an enclosed area [e.g., operating room (OR), examination/treatment room] to destroy harmful microorganisms or inhibit their activity on the surfaces of medical devices and equipment after they have been exposed to microbial contamination (bacteria, fungi, viruses, spores of bacteria). It typically consists of a programmable aerosol electrical generator, user controls, tubing and connectors, and a recess for holding a prefilled canister of the disinfectant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G0602034S0 | HIBCC |