FDA.reportPublic FDA data

PILLING

Primary DI
14026704611673
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN911413
Catalog number
1037829
Device description
DECANN STOPPER 9 3/4 CLOSURE
Published
2017-12-18
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
14026704611673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670461167314026704611673

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube decannulation capA device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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