FDA.report

Rospital Productos Medicos

Primary DI
30812460028217
Brand
Rospital Productos Medicos
Company
ATLAS MEDICAL PRODUCTS LLC
Model
FM3500
Catalog number
FM3500
Device description
FACE MASK TIE ON 3 PLY 50/BOX
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MSHRespirator, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
MSHRespirator, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30812460028217PackageGS140In Commercial Distribution
00812460028216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3081246002821730812460028217
00812460028216008124600282168124600282160812460028216

GMDN Terms

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

Contacts

PhoneEmail
7864739436levalenzuela17@gmail.com

Regulatory Flags

DUNS number
013112308
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
10812460026240Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
10812460026271Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
10812460026295Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460021344Rospital Productos MedicosAMPRG361002023-03-17
10812460025045Rospital Productos MedicosSBP22SBP222023-03-17
10812460020774Rospital Productos MedicosGS4021262022-10-21
10812460020828Rospital Productos MedicosCW500101CW5001012022-10-21
10812460021962Rospital Productos MedicosGS4021284021282022-10-21
10812460025083Rospital Productos MedicosGS402122GS4021222022-10-21
10812460026905Rospital Productos MedicosSY2021SY20212020-06-13
10812460026936Rospital Productos MedicosSY325SY3252020-06-13
10812460026943Rospital Productos MedicosSY321SY3212020-06-13
10812460026950Rospital Productos MedicosSY3215SY32152020-06-13
10812460026967Rospital Productos MedicosSY3225SY32252020-06-13

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