| Primary Device ID | 00868924000267 |
| NIH Device Record Key | e41207bd-51e8-4dbb-a898-322ff143426d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monitor Input Cable, Mikro-Cath to EP-Tracer System |
| Version Model Number | 850-5148 |
| Catalog Number | 850-5148 |
| Company DUNS | 058269648 |
| Company Name | MILLAR INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8326677100 |
| sales@millar.com | |
| Phone | 8326677100 |
| sales@millar.com | |
| Phone | 8326677100 |
| sales@millar.com | |
| Phone | 8326677100 |
| sales@millar.com | |
| Phone | 8326677100 |
| sales@millar.com |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868924000267 [Primary] |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00868924000267]
Ethylene Oxide
[00868924000267]
Ethylene Oxide
[00868924000267]
Ethylene Oxide
[00868924000267]
Ethylene Oxide
[00868924000267]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-26 |
| Device Publish Date | 2021-07-16 |
| 00868924000267 - Monitor Input Cable, Mikro-Cath to EP-Tracer System | 2021-07-26The 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. |
| 00868924000267 - Monitor Input Cable, Mikro-Cath to EP-Tracer System | 2021-07-26 The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Ca |
| 00868924000205 - Mikro-Cath Pressure Catheter | 2018-07-06 The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor |
| 00868924000212 - Pressure Control Unit PCU-2000 | 2018-07-06 The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Ti |
| 00868924000229 - TC-510 Pressure Control Unit | 2018-07-06 The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any standardized sensitivity Mikro-Tip® |
| 00868924000236 - Mikro-Tip Catheter Pulse Transducer | 2018-07-06 Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connecto |