FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00817492021815
·
Model: GENERATOR,O3Z-E,0-4GM/HR
·
MAR COR PURIFICATION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00817492021815
- Version / Model
- GENERATOR,O3Z-E,0-4GM/HR
- Catalog Number
- NA
- Company Name
- MAR COR PURIFICATION, INC.
- Labeler DUNS
- 019056181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-06
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fd4d5372-ee8b-4d03-a338-ffdfb3631533
Device Description
Ozone System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NII | Disinfectant, Dialysate Delivery System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46088 | Ozone generator, stationary | A fixed-location, mains electricity (AC-powered) device used to create and deliver ozone (O3) - also known as trioxygen. It typically produces a high electrical voltage between electrodes, to convert room air, or oxygen (O2) feed gas, into O3 when passed through the electrode gap. It usually includes measuring devices to determine output O3 concentration, and a mechanism to destroy internally the unused ozone; it is typically used at the site of application because it is not possible to store ozone. O3 has been used for various purposes in the laboratory, to disinfect/purify air and water, and in some clinical treatment of diseases. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817492021815 | GS1 |
Customer Contacts
- Phone
- 8006333080
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 19 | Pound | |
| Height | 17 | Inch | |
| Depth | 6 | Inch | |
| Width | 10 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – Degrees Fahrenheit