Primed

FDA UDI

Class II (US FDA UDI)

by priMED Medical Products Inc

Identity

Trade Name: PRIMED FDA UDI
Generic Name: Bone-conduction hearing aid, head-worn FDA UDI
Device Name: Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal. FDA UDI
Model / Reference: PM4-68394 FDA UDI
Description: Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal. FDA UDI

Identifiers

Primary DI / UDI-DI: 00842942017247 FDA UDI
FDA Product Code: FYA FDA UDI
GMDN Term: Bone-conduction hearing aid, head-worn FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone-conduction hearing aid, head-worn

Primed by priMED Medical Products Inc — 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: priMED Medical Products Inc

Sources (1)

FDA UDI a6ca4251-d02c-4214-88f9-ce2a2ac7f5a2 34 fields · synced Jun 8, 2026