FDA.reportPublic FDA data

CVS Health

Primary DI
10842942015974
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
795358
Device description
Medical Grade Pediatric Face Mask with Earloops, Leaf Print.
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OXZPediatric/Child Facemask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXZPediatric/Child FacemaskGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20842942015971PackageGS124In Commercial Distribution
10842942015974PrimaryGS10
00842942015977Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084294201597120842942015971
1084294201597410842942015974
00842942015977008429420159778429420159770842942015977

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, 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). It does not include an antimicrobial/antiviral agent(s) and 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. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
062312574
Device count
10
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23
00050428258590CVS Health8931212020-08-24
00050428265499CVS Health2414832020-02-28
00050428267189CVS Health9356862020-08-24
00050428279472CVS Health9843012020-03-02
00050428290118CVS Health8931262020-08-24
00050428307274CVS Health9356832020-08-24
00050428308615CVS Health5426302019-09-30
00050428311097CVS Health9356852020-08-24
00050428347928CVS Health8931252020-08-24
00050428354506CVS Health9843002019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479280919McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
40612479280920McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
00842942017490PRIMEDpriMED Medical Products IncOXZ2025-11-25
10842942017497PRIMEDpriMED Medical Products IncOXZ2025-11-25
00842942017452PRIMEDpriMED Medical Products IncOXZ2025-11-12
90842942017455PRIMEDpriMED Medical Products IncOXZ2025-11-12
00842942001888PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942003806PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942014314PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015267PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015830PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016059PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016066PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942001885PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942003803PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942014311PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015264PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015837PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016056PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016063PRIMEDpriMED Medical Products IncOXZ2025-07-14
10686864058592Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
20686864058599Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
10810141931227VIVIT SupplyVivit Supply LLCOXZ2023-12-15
20810141931224VIVIT SupplyVivit Supply LLCOXZ2023-12-15
10810141930893VIVIT SupplyVivit Supply LLCOXZ2023-09-15
20810141930890VIVIT SupplyVivit Supply LLCOXZ2023-09-15
20192253061724INSTAGARDCardinal Health 200, LLCOXZ2023-07-12
50192253061725INSTAGARDCardinal Health 200, LLCOXZ2023-07-12
00850022550249American Kid Disposable Face MaksArmbrust Inc.OXZ2023-01-27
10686864058097Medicom AssureMaskAMD Medicom IncOXZ2023-01-04