FDA.reportPublic FDA data

Argyle

Primary DI
20884527000286
Brand
Argyle
Company
Cardinal Health, Inc.
Model
47890
Catalog number
47890
Device description
Tracheostomy Care Kit
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884527000286PackageGS120In Commercial Distribution
10884527000289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452700028620884527000286
1088452700028910884527000289

GMDN Terms#

Term, Definition table
TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep 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
1
DM exempt
true
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
false
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
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
04035324009114TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010523TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010776TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010837TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010967TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010981TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011032TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011063TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011124TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011186TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011230TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011247TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011261TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011384TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011407TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011445TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011827TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012619TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012718TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013562TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013586TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013678TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013777TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013852TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013876TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013951TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014026TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014064TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014101TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014132TRACOE® comfortTracoe medical GmbHBTO2017-07-03