FDA.reportPublic FDA data

Kangaroo

Primary DI
10884521070042
Brand
Kangaroo
Company
Cardinal Health, Inc.
Model
8884751648
Catalog number
8884751648
Device description
Single Pass PEG Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521070042PrimaryGS10
20884521070049Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452107004210884521070042
2088452107004920884521070049

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253068762CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068779CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068809CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
00842071146412MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00842071146429MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00816340023162Transfer StrawNEODEVICES INCKNT2026-02-05
20885632464475HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-30
20197344200358MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200365MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200372MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200389MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20885632465069HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465076HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465083HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465106HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465113HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465120HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465137HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465144HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465175HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465281HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465335HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465342HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465380HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465434HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465465HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465489HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632464642HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464659HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464802HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22