FDA.report

Kangaroo

Primary DI
20192253012252
Brand
Kangaroo
Company
Cardinal Health 200, LLC
Model
8884751622E
Catalog number
8884751622E
Device description
Y-Port/Peg Adapter With ENFit™ Connection
Published
2024-02-27
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

Related Records

Product Codes

CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253012252PackageGS120In Commercial Distribution
50192253012253PackageGS110In Commercial Distribution
10192253012255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225301225220192253012252
5019225301225350192253012253
1019225301225510192253012255

GMDN Terms

TermDefinition
ENFit/non-ISO80369-standardized small-bore multichannel connectorA small, non-powered, noninvasive, small-bore, tubular connector with three or more connections, which includes both an ENFit connection(s) [designed according to ISO 80369-3 for enteral applications] and a connection(s) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), designed to connect an enteral device(s) [e.g., enteral syringe, feeding tube, administration set] with an ENFit connection(s) typically to tubing or a syringe. It does not have a Luer or ENLock connection(s), and does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

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
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

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