FDA.reportPublic FDA data

Kangaroo

Primary DI
50885380166004
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
1KCP
Catalog number
1KCP
Device description
Connect ENPlus Spike ENtelliSet Anti-free flow
Published
2020-09-04
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
LZHPump, infusion, enteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153074000Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien2016-07-06LZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380166006PrimaryGS10
50885380166004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538016600610885380166006
5088538016600450885380166004

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253009675KangarooCardinal Health 200, LLCLZH2026-05-12
10885380193071KangarooCardinal Health 200, LLCLZH2026-03-16
50885380193079KangarooCardinal Health 200, LLCLZH2026-03-16
10192253068900KangarooCardinal Health 200, LLCLZH2025-09-30
10192253068917KangarooCardinal Health 200, LLCLZH2025-09-30
00197886002300Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008203Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008210Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886002304Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886008207Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00704411019797SENTINEL® Enteral Feeding PumpAMSINO INTERNATIONAL, INC.LZH2025-06-25
03660812138345PUGGLEMEDWIN FRANCELZH2025-06-11
53660812136780PUGGLEMEDWIN FRANCELZH2025-06-11
10192253011135KangarooCardinal Health 200, LLCLZH2025-05-28
50192253011133KangarooCardinal Health 200, LLCLZH2025-05-28
10192253008456KangarooCardinal Health 200, LLCLZH2025-05-19
50192253008454KangarooCardinal Health 200, LLCLZH2025-05-19
10192253009682KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009859KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009965KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009680KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009857KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009963KangarooCardinal Health 200, LLCLZH2025-05-02
10192253008418KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008432KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008416KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008430KangarooCardinal Health 200, LLCLZH2025-04-29
10885380184567KangarooCardinal Health 200, LLCLZH2025-03-23
10192253008159KangarooCardinal Health 200, LLCLZH2024-12-16
10192253023107KangarooCardinal Health 200, LLCLZH2024-12-16