FDA.report

Medichoice

Primary DI
50885632100541
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
PG4-1573
Device description
Mask Procedure Face PRIMAGARD160 Anti-Fog Foam Anti Glare Strip Stretchy Earloop With Anti Glare Visor Foam Strip Aluminum Nose Piece Indigo Disposable Not Made With Natural Rubber Latex MediChoice
Published
2016-08-20
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

Related Records

Product Codes

CodeName
FXXMask, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50885632100541PackageGS14In Commercial Distribution
10885632100543PrimaryGS10
60885632100548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088563210054150885632100541
1088563210054310885632100543
6088563210054860885632100548

GMDN Terms

TermDefinition
Eye splash shield, single-useA non-sterile device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
25
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
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20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

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