FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Panasonic
DI: 04987905300069
·
Model: MCO-19M-PA
·
PHC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Panasonic
- Primary DI
- 04987905300069
- Version / Model
- MCO-19M-PA
- Company Name
- PHC CORPORATION
- Labeler DUNS
- 691795268
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-01-11
- Public Version Status
- Update
- Public Device Record Key
- 7b21f881-9c42-41fb-8abf-410706f4d57c
- Distribution End Date
- 2016-09-30
Device Description
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
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
- 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 |
|---|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40520 | Carbon dioxide laboratory incubator | A mains electricity (AC-powered) incubator in which a fixed temperature and carbon dioxide (CO2) controlled conditions can be achieved and maintained. It is used for the incubation of biological and chemical materials. The percentage mixture of carbon dioxide and other gases, typically oxygen, can be different depending on the use and device type. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987905300069 | GS1 |