FDA UDI
In Commercial Distribution
🇺🇸 United States
Monitor Input Cable, Mikro-Cath to EP-Tracer System
DI: 00868924000267
·
Model: 850-5148
·
MILLAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Monitor Input Cable, Mikro-Cath to EP-Tracer System
- Primary DI
- 00868924000267
- Version / Model
- 850-5148
- Catalog Number
- 850-5148
- Company Name
- MILLAR INC.
- Labeler DUNS
- 058269648
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 1
- Public Version Date
- 2021-07-26
- Public Version Status
- New
- Public Device Record Key
- e41207bd-51e8-4dbb-a898-322ff143426d
Device Description
The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Cardiotek GmbH medical device as detailed below: EP-Tracer 38, EP-Tracer 70, EP-Tracer 102, when used with the following system configurations: EP-Tracer Portable, EP-Tracer Stationary, EP-Tracer ProCart. The 850-5148 cable is 10 feet long. The cable is supplied nonsterile.
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Cardiovascular | 870.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46250 | Transducer signal amplifier | An electronic device that increases current, voltage, or power to intensify the electrical signal sent to or received from a transducer (e.g., electroacoustic, electro-optical, electromechanical), sometimes providing impedance matching. It will provide an electrical interface between a physiological transducer and a patient monitor or patient monitoring system that is used to monitor pressures such as, noninvasive and invasive blood pressure, oesophageal pressures, urinary tract pressures, intrauterine pressures and intraocular pressures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868924000267 | GS1 |
Customer Contacts
- Phone
- 8326677100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 104 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity