FDA.reportPublic FDA data

P&P Medical Surgical LLC

Primary DI
G026010001
Brand
P&P Medical Surgical LLC
Company
P&P Medical Surgical LLC
Model
01000
Device description
Disposable Medical Face Masks Sanitary Dental Surgical Hypoallergenic with Elastic Ear Loops 3-Ply Thick Resistance to Fluid & Blood Cotton Filter for Pollen Allergies & Dust Box of 50
Published
2022-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G026010001PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022925151
Device count
1
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G026070501P&P Medical Surgical LLC070502022-02-14
G026071501P&P Medical Surgical LLC071502022-02-14
G026072501P&P Medical Surgical LLC072502022-02-14
G026073501P&P Medical Surgical LLC073502022-02-14
G026080001P&P Medical Surgical LLC080002022-02-14
G026055001P&P Medical Surgical LLC055002022-02-16
G026055501P&P Medical Surgical LLC055502022-02-16
G026056001P&P Medical Surgical LLC056002022-02-16
G026009501P&P Medical Surgical LLC009502022-02-14
G026015001P&P Medical Surgical LLC015002022-02-14
G026015501P&P Medical Surgical LLC015752022-02-14
G026016001P&P Medical Surgical LLC016002022-02-14
G026017001P&P Medical Surgical LLC017002022-02-14
G026018001P&P Medical Surgical LLC018002022-02-14
G026060001P&P Medical Surgical LLC060002022-02-14
G026060751P&P Medical Surgical LLC060752022-02-14
G026061001P&P Medical Surgical LLC061002022-02-14
G026062001P&P Medical Surgical LLC062002022-02-14
G026063001P&P Medical Surgical LLC063002022-02-14
G026095001P&P Medical Surgical LLC095002022-02-14

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Primary DI, Brand, Company table
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