← Back to catalogue

Face Masks

FDA UDI

Class II (US FDA UDI)

by Omnia Spa

Identity

Trade Name
FACE MASKS FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING FDA UDI
Model / Reference
30.M1307.00 FDA UDI
Description
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING FDA UDI

Identifiers

Primary DI / UDI-DI
08056646501380 FDA UDI
510(k) Number
K911334 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Face Masks by Omnia Spa — 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.

Cleared under the same submission

K911334 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Omnia Spa

Sources (1)

  • FDA UDI b07e89e3-4038-4ce2-9335-a1038e750a57 36 fields · synced Jun 8, 2026