DEVICE: Critical Cover (10817583020144)

Device Identifier (DI) Information

Critical Cover
695MED
In Commercial Distribution
695MED
Alpha Pro Tech, Inc.
10817583020144
GS1

35
102710720 *Terms of Use
N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57794 Surgical/medical respirator, non-antimicrobial, single-use
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MSH Respirator,Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092824 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2ce6c14e-e263-4a48-920d-d8510fba64dd
June 16, 2025
8
November 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20817583020141 6 10817583020144 In Commercial Distribution CASE
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00817583020147 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-520-281-0127
XX@XX.XX
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