FDA.reportPublic FDA data

PRIMED

Primary DI
00842942016066
Brand
PRIMED
Company
priMED Medical Products Inc
Model
PG4-1663
Device description
ASTM Level 3 Pediatric Mask, Ear Loops, Indigo
Published
2025-07-14
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
10842942016063PackageGS110In Commercial Distribution
00842942016066PrimaryGS10
90842942016069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201606310842942016063
00842942016066008429420160668429420160660842942016066
9084294201606990842942016069

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
253287569
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842942012952PRIMEDPM1-21402026-05-15
00842942012969PRIMEDPM1-21452026-05-15
00842942012976PRIMEDPM1-21482026-05-15
00842942012983PRIMEDPM1-21542026-05-15
00842942013140PRIMEDPM1-22122026-05-15
00842942013157PRIMEDPM1-22182026-05-15
00842942013164PRIMEDPM1-22362026-05-15
00842942013171PRIMEDPM1-22402026-05-15
00842942013348PRIMEDPM1-23242026-05-15
00842942013355PRIMEDPM1-23302026-05-15
00842942013362PRIMEDPM1-23362026-05-15
00842942013379PRIMEDPM1-23402026-05-15
00842942013386PRIMEDPM1-23452026-05-15
00842942013393PRIMEDPM1-23482026-05-15
00842942013409PRIMEDPM1-23542026-05-15
00842942013416PRIMEDPM1-23722026-05-15
00842942013577PRIMEDPM1-24242026-05-15
00842942013584PRIMEDPM1-24362026-05-15
00842942013591PRIMEDPM1-24402026-05-15
00842942014833PRIMEDPM1-22242026-05-15

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
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
10842942015974CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOXZ2023-09-12
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