FDA.report

CVS Health

Primary DI
00842942015960
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
465418
Device description
Medical Grade Face Masks with Ear Loops, Blue
Published
2022-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXXMask, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20842942015964PackageGS124In Commercial Distribution
10842942015967PrimaryGS10
00842942015960Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084294201596420842942015964
1084294201596710842942015967
00842942015960008429420159608429420159600842942015960

GMDN Terms

TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
062312574
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10
00050428005897CVS 695560XL cuff2025-12-10
10050428005832CVS 695534BM222025-12-09
10050428005856CVS 695537BM432025-12-09
10842942017541CVS4608662025-12-08

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