FDA.reportPublic FDA data

Kangaroo

Primary DI
10885380198793
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
1000NT-T
Catalog number
1000NT-T
Device description
Kangaroo NTrainer Handpiece Tubing
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380198791PrimaryGS10
10885380198793Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538019879150885380198791
1088538019879310885380198793

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260242060200DIERS iEMGDIERS International GmbHHCC2026-03-09
00852168008004LIFE SystemHARMONIC ENERGETIC TECHHCC2026-03-05
07290019255055SCENTIFIC Respiratory BiofeedbackAPPSCENT MEDICAL LTDHCC2026-02-16
08719481550165NeXus Q24Mind Media Europe B.V.HCC2025-12-03
00860001790849InTandemMedrhythms, Inc.HCC2025-10-14
00860001790856MoviveMedrhythms, Inc.HCC2025-10-14
00860001790825InTandem Education UnitMedrhythms, Inc.HCC2025-06-13
00860001790832Movive Education UnitMedrhythms, Inc.HCC2025-06-13
10885380198786KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198878KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198885KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198892KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198908KangarooCardinal Health 200, LLCHCC2025-03-12
10885380200199KangarooCardinal Health 200, LLCHCC2025-03-12
00860001790818MoviveMedrhythms, Inc.HCC2025-03-10
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00855846007214MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007221MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007177MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007184MyoPro 2xMyomo, Inc.HCC2024-09-20
00092237626573Richmar EMG SoftwareCOMPASS HEALTH BRANDS CORP.HCC2024-06-28
00851679007360Trigno Avanti SensorDELSYS, INC.HCC2024-05-06
00851679007377Trigno CentroDELSYS, INC.HCC2024-05-06
00851679007384Trigno Charge-16DELSYS, INC.HCC2024-05-06