FDA.report

PILLING

Primary DI
14026704611642
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN900869
Catalog number
1037826
Device description
DECANN STOPPER 6 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

Related Records

Contact Domains

Product Codes

CodeName
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications

CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704611642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1402670461164214026704611642

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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