FDA.reportPublic FDA data

Wi-Box™

Primary DI
05414734054164
Brand
Wi-Box™
Company
ST. JUDE MEDICAL, INC.
Model
PSU Kit
Catalog number
C12785
Device description
Cable
Published
2016-03-16
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
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734054164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734054164054147340541645414734054164

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Special Storage Condition, Specify00Store at room temperature in a dry place. Do not use if package is damaged.
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05415067016683NA231623162015-09-08

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Primary DI, Brand, Company table
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00850005949671BioButton Charging StationBIOINTELLISENSE, INC.DRG2025-11-19
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UA2251DA1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251SA1UbiqVue Lifesignals, Inc.DRG2025-04-22
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00850064210194Central Hub SpeakerSibel Health Inc.DRG2025-03-27
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.DRG2025-03-26
00850064210088ANNE Limb Sensor KitSibel Health Inc.DRG2025-03-26
00850064210156ANNE Limb SensorSibel Health Inc.DRG2025-03-26
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00850005949565BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.DRG2025-02-19
00850005949596BioButton Charging StationBIOINTELLISENSE, INC.DRG2025-02-19
00850005949442BioButton Rechargeable Device, Multi-PatientBIOINTELLISENSE, INC.DRG2025-02-11
B353UB25501UbiqVue MultiparameterLifesignals, Inc.DRG2024-11-29
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2024-06-19
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyDRG2024-04-30
00195278713193Portrait HUBXBGE Healthcare Finland OyDRG2024-04-30
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00850005949343BioButton At-Home Kit with Power Adaptor, Adhesives and BioButtonBIOINTELLISENSE, INC.DRG2023-11-16
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