FDA.reportPublic FDA data

Premier Decann Stopper

Primary DI
00348783011180
Brand
Premier Decann Stopper
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1037838
Device description
DECAN STOP SZ 8 CLOSURE FULL
Published
2026-06-08
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
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884015000PREMIER DECANNULATION STOPPERPremier Dental1988-11-03BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783011180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783011180003487830111803487830111800348783011180

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

Regulatory Flags#

DUNS number
014789663
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
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
00348783008500Premier Excavators10034402026-06-08
00348783008517Premier Excavators10034412026-06-08
00348783008524Premier Excavators10034422026-06-08
00348783008531Premier Excavators10034432026-06-08
00348783008548Premier Excavators10034462026-06-08
00348783008555Premier Excavators10034472026-06-08
00348783008562Premier Excavators10034482026-06-08
00348783008579Premier Excavators10034492026-06-08
00348783008609Premier Excavators10034532026-06-08
00348783008616Premier Excavators10034542026-06-08
00348783008623Premier Excavators10034622026-06-08
00348783008647Premier Excavators10034642026-06-08
00348783008661Premier Excavators10038412026-06-08
00348783008685Premier Excavators10038502026-06-08
00348783008692Premier Excavators10038832026-06-08
00348783008708Premier Excavators10038842026-06-08
00348783008715Premier Excavators10038852026-06-08
00348783011142Premier Decann Stopper10378342026-06-08
00348783011159Premier Decann Stopper10378352026-06-08
00348783011166Premier Decann Stopper10378362026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783011142Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-06-08
00348783011159Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-06-08
00348783011166Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-06-08
00348783011173Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-06-08
00348783011135Premier Decann StopperPREMIER DENTAL PRODUCTS COMPANYBTO2026-05-27
10192253052893ArgyleCardinal Health 200, LLCBTO2024-07-15
10192253052909ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052916ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052923ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052930ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052954ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052978ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052985ArgyleCardinal Health 200, LLCBTO2024-02-16
10192253052992ArgyleCardinal Health 200, LLCBTO2024-02-16
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14026704646699RUSCHTELEFLEX INCORPORATEDBTO2019-07-01
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M6898250001010Mojo RFR First Responder SetSafeguard US Operating, LLCBTO2018-06-04
M6898260001010Mojo RFR Airway & Respiration SetSafeguard US Operating, LLCBTO2018-06-04
10884521751354ShileyCovidien LPBTO2018-02-06
10884521751361ShileyCovidien LPBTO2018-02-06
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10381780038603Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038610Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09
10381780038627Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBTO2017-10-09