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Patient Safety Mask

EUDAMEDFDA UDI

Class I (EU MDR)

Ref GCPATModel Face Masks and Shields

by Crosstex International Inc

Identity

Trade Name
Patient Safety Mask EUDAMED
Patient Safety Mask with Shield FDA UDI
Generic Name
Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Device Name
Patient Half Mask, W/Visor, White FDA UDI
Model / Reference
Face Masks and Shields EUDAMED
GCPAT EUDAMEDFDA UDI
Description
Patient Half Mask, W/Visor, White FDA UDI

Identifiers

Catalog Number
GCPAT FDA UDI
Primary DI / UDI-DI
10732224120369 EUDAMEDFDA UDI
Basic UDI-DI
0732224FaceMask&ShieldQM EUDAMED
Unit of Use DI
00732224120362 EUDAMED
FDA Product Code
FXX FDA UDI
EMDN Code
T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
GMDN Term
Surgical/medical respirator, non-antimicrobial, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Patient Safety Mask by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crosstex International Inc
EUDAMED SRN
US-MF-000009642
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 10896b04-07d0-4d15-a472-8bd11a304b2e 61 fields · synced Jun 19, 2026
  • FDA UDI e296874b-6441-423b-8276-c41444fde874 35 fields · synced May 30, 2026