FDA.reportPublic FDA data

Kangaroo

Primary DI
20884521064840
Brand
Kangaroo
Company
Cardinal Health, Inc.
Model
674626
Catalog number
674626
Device description
924 Proximal Spike Set
Published
2019-12-30
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
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521064840PackageGS130In Commercial Distribution
10884521064843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452106484020884521064840
1088452106484310884521064843

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding noninvasive-component setA collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403211423Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2025-12-19
10885403423208Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.FRN2025-12-19
00816989021468HK Klein Infiltration Pump+HK SURGICAL INC.FRN2025-09-29
50197886011239Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013172Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013189Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013196Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
00850017421202RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421219RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421226RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421233RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421240RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421264RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421271RemunityPROUnited Therapeutics CorporationFRN2025-08-07
20197886008214Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-07-07
10885403519291BD AlarisCAREFUSION 303, INC.FRN2025-06-25
M335400011ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
M335400031ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
B510IP200ADVANCED INFUSION PUMPADVANCED INSTRUMENTATIONS, INC.FRN2025-02-04
00811505030467Ivenix Infusion SystemFresenius Kabi AGFRN2024-12-06
05713495001043VYAFUSER™Phillips-Medisize A/SFRN2024-11-13
27290109155306Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
00816989021437HK Klein TDD PumpHK SURGICAL INC.FRN2024-08-29
10885403519284AlarisCAREFUSION 303, INC.FRN2024-05-24
40616258024415MEDRAD® Intego Patient Administration SetBayer Medical Care Inc.FRN2024-05-06
40616258024835MEDRAD® Intego Sterile DisposablesBayer Medical Care Inc.FRN2024-05-06
00862492000353Eitan MedicalOPTUMHEALTH CARE SOLUTIONS, INC.FRN2024-04-24
04987488102241PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102258PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102265PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12