FDA.reportPublic FDA data

ProGear

Primary DI
00852212003344
Brand
ProGear
Company
PRESTIGE AMERITECH, LTD.
Model
FM85011-CCM1
Device description
Imprints™ Earloop Economy (USA)
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
10852212003341PackageGS110In Commercial Distribution
00852212003344PrimaryGS10
80852212003340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085221200334110852212003341
00852212003344008522120033448522120033440852212003344
8085221200334080852212003340

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.

Contacts#

Phone, Email table
PhoneEmail
18664018972orders@prestigeam.com

Regulatory Flags#

DUNS number
199692794
Device count
50
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852212003269ProKidsFM85030-CCM12016-09-26
00852212003214ProKidsFM850302016-09-26
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29
00811220030063PremierPro881988192020-08-29
00811220030278PremierPro635563552020-08-02
00811220030308PremierPro500150012020-06-26
00811220030315PremierPro500250022020-06-26
00811220030322PremierPro500350032020-06-26
00811220030339PremierPro500450042020-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056441261Target Up&UpArmbrust Inc.OXZ2026-06-25
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
10842942015974CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOXZ2023-09-12
20192253061724INSTAGARDCardinal Health 200, LLCOXZ2023-07-12
50192253061725INSTAGARDCardinal Health 200, LLCOXZ2023-07-12