T-Piece Adapter

FDA UDI

Class I (US FDA UDI)

by D R Burton Healthcare, Llc

Identity

Trade Name: T-PIECE ADAPTER FDA UDI
Generic Name: Breathing mouthpiece, single-use FDA UDI
Device Name: 22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. MOUTHPIECE ADAPTER FDA UDI
Model / Reference: 1 FDA UDI
Description: 22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. MOUTHPIECE ADAPTER FDA UDI

Identifiers

Primary DI / UDI-DI: 10851232007674 FDA UDI
FDA Product Code: BYP FDA UDI
GMDN Term: Breathing mouthpiece, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing mouthpiece, single-use

T-Piece Adapter by D R Burton Healthcare, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Disposable Mouthpiece 27mm OD — Vacumed · Class I
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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 I	Pending data

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Manufacturer

Manufacturer: D R Burton Healthcare, Llc

Sources (1)

FDA UDI e1b5f1bb-92b4-44f1-8a7a-97dd07279edb 34 fields · synced Jun 8, 2026