FDA.report

Kangaroo

Primary DI
50885380184183
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
ER100S
Catalog number
ER100S
Device description
Kangaroo OMNI Burette ENtelliSet
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZHPump, infusion, enteral

Product Code Classifications

CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885380184183PackageGS130In Commercial Distribution
10885380184185PrimaryGS10

GMDN Terms

TermDefinition
Enteral feeding pumpA mains electricity (AC-powered) device designed to create pressure to accurately control the rates of flow of nutrient fluids directly into the stomach, duodenum, or jejunum, via enteral tubing, in patients who are unable or unwilling to consume adequate nutrients.

Device Sizes

TypeValueUnit
Total Volume100Milliliter

Sterilization Methods

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
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20197886008207Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00704411019797SENTINEL® Enteral Feeding PumpAMSINO INTERNATIONAL, INC.LZH2025-06-25
53660812136780PUGGLEMEDWIN FRANCELZH2025-06-11
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