AccessGUDID - DEVICE: Monitor Input Cable, Mikro-Cath to EP-Tracer System (00868924000267)

GUDID

Device Identifier (DI) Information

Brand Name: Monitor Input Cable, Mikro-Cath to EP-Tracer System
Version or Model: 850-5148
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 850-5148
Company Name: MILLAR INC.

Primary DI Number: 00868924000267
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058269648 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRQ	Amplifier And Signal Conditioner, Transducer Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Handling Environment Temperature: between 59 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e41207bd-51e8-4dbb-a898-322ff143426d
Public Version Date: July 26, 2021
Public Version Number: 1
DI Record Publish Date: July 16, 2021