Premier

FDA UDI

Class II (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name: Premier FDA UDI
Generic Name: Tracheostomy tube decannulation cap FDA UDI
Device Name: Decan Stopper Size 5 Closure Full FDA UDI
Model / Reference: 8100936 FDA UDI
Description: Decan Stopper Size 5 Closure Full FDA UDI

Identifiers

Primary DI / UDI-DI: 00856402006306 FDA UDI
FDA Product Code: BTO FDA UDI
GMDN Term: Tracheostomy tube decannulation cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostomy tube decannulation cap

Premier by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Premier Dental Products Company

Sources (1)

FDA UDI 34bdd014-c1e3-4262-a512-d0a124a2016a 33 fields · synced May 30, 2026