FDA.reportPublic FDA data

Metro-Pacifica

Primary DI
00609626000007
Brand
Metro-Pacifica
Company
Metro Medical Supply
Model
ELM-970
Device description
Face mask with regular earloops - White
Published
2018-09-20
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
00609626000007PrimaryGS10
00609626000014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609626000007006096260000076096260000070609626000007
00609626000014006096260000146096260000140609626000014

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
50
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
00609626000021Metro-PacificaELM-9702018-09-20
00609626000038Metro-PacificaELM-9802018-10-01
00609626062630Metro-PacificaELM-9802018-10-01
00609626062647Metro-PacificaELM-970ES2018-10-01
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

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