FDA.reportPublic FDA data

Monitor Input Cable, Mikro-Cath to EP-Tracer System

Primary DI
00868924000267
Brand
Monitor Input Cable, Mikro-Cath to EP-Tracer System
Company
MILLAR INC.
Model
850-5148
Catalog number
850-5148
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.
Published
2021-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRQAmplifier And Signal Conditioner, Transducer Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000267008689240002678689240002670868924000267

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature59 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8326677100sales@millar.com

Regulatory Flags#

DUNS number
058269648
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000205Mikro-Cath Pressure Catheter825-0101825-01012016-10-03
00868924000212Pressure Control Unit PCU-2000PCU-2000880-01292016-09-30
00868924000229TC-510 Pressure Control UnitTC-510851-59182016-09-30
00868924000236Mikro-Tip Catheter Pulse TransducerSPT-301808-10192016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCDRQ2025-06-30
04931921017159CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-30
04931921017166CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-01
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
08714729882985LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729882992LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
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