FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632143830
·
Model: CL8410
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
14
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632143830
- Version / Model
- CL8410
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 14
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 3
- Public Version Date
- 2018-09-07
- Public Version Status
- Update
- Public Device Record Key
- f2d34884-c89f-474d-9568-c05cadbeda14
Device Description
Connector Set Electrode Cam 14 AM4 AM5 Banana 14 Per Set Reusable Not Made With Natural Rubber Latex MediChoice
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58068 | Electrosurgical/ultrasonic surgical system tester interface | A non-sterile electrical connecting device designed to provide an interface between a commonly used electrical output analyser/equipment and an electrosurgical system generator and an ultrasonic surgical system generator, or a combination electrosurgical/ultrasonic surgical system generator when being tested for power output in a non-clinical setting. Commonly known as a verification key, it is typically used by a hospital clinical engineer when testing the generators during routine maintenance or inspection and provides standard connector components (e.g., banana plug receptacles) to allow simpler interface with a custom generator connector. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885632143830 | GS1 | ||||
| Unit of Use | 60885632143835 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Freezing and Excessive Heat
- Type
- Special Storage Condition, Specify