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John Bunn

FDA UDI

Class II (US FDA UDI)

by GF Health Products, Inc

Identity

Trade Name
JOHN BUNN FDA UDI
Generic Name
Tracheoesophageal speech valve occluder, non-valved FDA UDI
Device Name
Jackson Trachea Plug FDA UDI
Model / Reference
3255-8 FDA UDI
Description
Jackson Trachea Plug FDA UDI

Identifiers

Primary DI / UDI-DI
M368325581 FDA UDI
FDA Product Code
BTO FDA UDI
GMDN Term
Tracheoesophageal speech valve occluder, non-valved 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Tracheoesophageal speech valve occluder, non-valved

John Bunn by GF Health Products, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheoesophageal speech valve occluder, non-valved.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GF Health Products, Inc

Sources (1)

  • FDA UDI ac5b2729-ddd0-485a-a1b9-a754769cb66e 34 fields · synced Jun 1, 2026