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Regard™

FDA UDI

Class II (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Behavioral Health Mask FDA UDI
Model / Reference
A3PMSKULBH-REG FDA UDI
Description
Behavioral Health Mask FDA UDI

Identifiers

Catalog Number
A3PMSKULBH-REG FDA UDI
Primary DI / UDI-DI
00326053118708 FDA UDI
510(k) Number
K031353 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

Yes

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

No

FDA UDI

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

Regard™ by Resource Optimization & Innovation, L.l.c. — 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

K031353 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resource Optimization & Innovation, L.l.c.

Sources (1)

  • FDA UDI 09fd02d9-0dd3-47ce-8b72-61c13f0b8766 35 fields · synced May 30, 2026