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Primed

FDA UDI

Class II (US FDA UDI)

by priMED Medical Products Inc

Identity

Trade Name
PRIMED FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Mask with visor, PRIMASAURUS P160 Surgical Tie, Anti-fog Foam, Anti-glare, Dinosaurs FDA UDI
Model / Reference
PG4-5083 FDA UDI
Description
Mask with visor, PRIMASAURUS P160 Surgical Tie, Anti-fog Foam, Anti-glare, Dinosaurs FDA UDI

Identifiers

Primary DI / UDI-DI
00842942001895 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use 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

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, non-antimicrobial, single-use

Primed by priMED Medical Products Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, non-antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
priMED Medical Products Inc

Sources (1)

  • FDA UDI 90eb2816-cc12-4956-8a76-3dcb52573f71 34 fields · synced Jun 8, 2026