FDA UDI
Not in Commercial Distribution
🇺🇸 United States
mini Powered Cole Isolation Device
DI: 00810072351005
·
Model: mPCID
·
Cole Instruments Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- mini Powered Cole Isolation Device
- Primary DI
- 00810072351005
- Version / Model
- mPCID
- Catalog Number
- 910.000
- Company Name
- Cole Instruments Inc
- Labeler DUNS
- 078573265
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-04
- Public Version
- 3
- Public Version Date
- 2024-07-26
- Public Version Status
- Update
- Public Device Record Key
- 9953035d-5a78-4888-8321-791c3253c5a9
- Distribution End Date
- 2024-07-25
Device Description
mini Powered Cole Isolation Device (mPCID). Sterilize handpiece before first use and before each use.
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
- No
- 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 |
|---|---|---|---|---|
| MOQ | Battery, Replacement, Rechargeable | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60308 | Electrical breakout box | A portable, passive, electrical device intended to separate the signals in a multiconductor cable into terminal connections in order to test circuitry independently. It is typically presented as a box with a multiconductor input/output and a series of terminal connections. It is typically used by a healthcare provider (i.e., clinical technician) in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810072351005 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 84.3 – 101.3 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius