FDA.reportPublic FDA data

Metro-Pacifica

Primary DI
00609626062647
Brand
Metro-Pacifica
Company
Metro Medical Supply
Model
ELM-970ES
Device description
Face mask with regular earloops + shield - White
Published
2018-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911334000MASK, SURGICAL APPARELThai Hospital Products Co., Ltd.1991-08-29FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609626062647PrimaryGS10
00609626062654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609626062647006096260626476096260626470609626062647
00609626062654006096260626546096260626540609626062654

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(615) 312-9800customerservice@metromedical.com

Regulatory Flags#

DUNS number
080604969
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609626063101METRO-PACIFICANPF-1150NPF-11502019-04-26
00609626063132METRO-PACIFICANPF-1160NPF-11602019-04-26
00609626063163METRO-PACIFICANPF-1170NPF-11702019-04-26
00609626063194METRO-PACIFICANPF-1180NPF-11802019-04-26
00609626063224METRO-PACIFICANPF-1190NPF-11902019-04-26
00609626063255METRO-PACIFICANPF-1195NPF-11952019-04-26
00609626063439METRO-PACIFICAAN-2550AN-25502019-04-26
00609626063460METRO-PACIFICAAN-2560AN-25602019-04-26
00609626063491METRO-PACIFICAAN-2570AN-25702019-04-26
00609626063521METRO-PACIFICAAN-2580AN-25802019-04-26
00609626063552METRO-PACIFICAAN-2590AN-25902019-04-26
00609626000007Metro-PacificaELM-9702018-09-20
00609626000021Metro-PacificaELM-9702018-09-20
00609626000038Metro-PacificaELM-9802018-10-01
00609626062630Metro-PacificaELM-9802018-10-01
00609626062661Metro-PacificaELM-970ES2018-10-01
00609626000199METRO-PACIFICAT-1060T-10602019-06-12
00609626000229METRO-PACIFICAT-1070T-10702019-06-12
00609626000250METRO-PACIFICAT-1080T-10802019-06-12
00609626000281METRO-PACIFICAT-1090T-10902019-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05