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SafeSource Direct Level 1 Procedure Mask with Ear Loops

FDA UDI

Class II (US FDA UDI)

by Safesource Direct, L.L.C.

Identity

Trade Name
SafeSource Direct Level 1 Procedure Mask with Ear Loops FDA UDI
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Device Name
Blue ASTM Level 1 Procedure Mask with soft ear loops FDA UDI
Model / Reference
PM3001 FDA UDI
Description
Blue ASTM Level 1 Procedure Mask with soft ear loops FDA UDI

Identifiers

Primary DI / UDI-DI
00850037747146 FDA UDI
510(k) Number
K221134 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

SafeSource Direct Level 1 Procedure Mask with Ear Loops by Safesource Direct, 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

K221134 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Safesource Direct, L.L.C.

Sources (1)

  • FDA UDI dc11853c-5b9c-431f-baa0-d6720949a913 35 fields · synced May 30, 2026