FDA.reportPublic FDA data

Kangaroo

Primary DI
40884521657602
Brand
Kangaroo
Company
Cardinal Health, Inc.
Model
8884700207E
Catalog number
8884700207E
Device description
Pump Set Extension Tubing with ENFit Connection
Published
2017-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K141479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141479000KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORSCovidien2014-12-23LZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884521657602PackageGS130In Commercial Distribution
30884521657605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088452165760240884521657602
3088452165760530884521657605

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube extension, sterileA sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Feet

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

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