FDA.report

Halyard

Primary DI
30680651623554
Brand
Halyard
Company
O&M HALYARD, INC.
Model
62355
Catalog number
62355
Device description
HYH,-,RESP,-,SML,300
Published
2016-04-28
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

Contact Domains

Product Codes

CodeName
FXXMask, surgical
MSHRespirator, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2
MSHRespirator, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651623554PackageGS16In Commercial Distribution
20680651623557PrimaryGS10
90680651623556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065162355430680651623554
2068065162355720680651623557
9068065162355690680651623556

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
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags

DUNS number
081057389
Device count
50
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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30680651497315Halyard49731497312026-03-04
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30680651331015Halyard33101331012020-11-16
30680651331503Halyard33150331502020-11-16
30680651332012Halyard33201332012020-11-16
30680651334955Halyard33495334952020-11-16
30680651335006Halyard33500335002020-11-16
30680651337253Halyard33725337252020-11-16
90680651335107Halyard33510335102020-11-16
90680651337248Halyard33724337242020-11-16
30680651493645Halyard49364493642025-09-23
30680651493652Halyard49365493652025-09-23
30680651493409Halyard49340493402025-09-19
30680651493423Halyard49342493422025-09-19

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