FDA.reportPublic FDA data

ViewFlex™

Primary DI
05415067013750
Brand
ViewFlex™
Company
ST. JUDE MEDICAL, INC.
Model
H701375
Catalog number
H701375
Device description
Catheter Interface Module
Published
2016-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRJSYSTEM, SIGNAL ISOLATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRJSystem, Signal IsolationCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067013750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067013750054150670137505415067013750

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57 KiloPascal101 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Handling Environment Temperature18 Degrees Celsius26 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Handling Environment Temperature64 Degrees Fahrenheit79 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry. Do not use if package is damaged.
Storage Environment Atmospheric Pressure57 KiloPascal101 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature18 Degrees Celsius26 Degrees Celsius
Storage Environment Temperature64 Degrees Fahrenheit79 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067049278ViewFlex™ST. JUDE MEDICAL, INC.DRJ2024-01-12
05415067049285ViewFlex™ST. JUDE MEDICAL, INC.DRJ2024-01-12
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DRJ2020-06-18
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHDRJ2018-12-18
20884838072248Spirometry SensorPhilips Medizin Systeme Böblingen GmbHDRJ2017-01-20
05415067002907ViewFlex™ST. JUDE MEDICAL, INC.DRJ2016-06-09
05415067002655ViewFlex™ST. JUDE MEDICAL, INC.DRJ2016-05-06
05415067002969ViewFlex™ST. JUDE MEDICAL, INC.DRJ2016-05-06
05415067013743ViewFlex™ST. JUDE MEDICAL, INC.DRJ2016-05-06