FDA.reportPublic FDA data

Halyard

Primary DI
30680651470011
Brand
Halyard
Company
O&M HALYARD, INC.
Model
47001
Catalog number
47001
Device description
HALYARD* Poly-Coated Fluid Resistant Gown, Knit Cuffs, White, Universal
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651470011PackageGS110In Commercial Distribution
20680651470014PrimaryGS10
90680651470013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147001130680651470011
2068065147001420680651470014
9068065147001390680651470013

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
10
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30680651489532Halyard48953489532026-03-12
30680651497285Halyard49728497282026-03-04
30680651497292Halyard49729497292026-03-04
30680651497308Halyard49730497302026-03-04
30680651497315Halyard49731497312026-03-04
30680651497322Halyard49732497322026-03-04
30680651596810Halyard59681596812020-11-16
30680651596889Halyard59688596882020-11-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10842942015448PRIMEDpriMED Medical Products IncFME2026-02-10
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26975803530888GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10842942017527PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942017534PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942007825PRIMEDpriMED Medical Products IncFME2025-07-21
10842942008204PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009348PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009355PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009362PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009379PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009553PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009560PRIMEDpriMED Medical Products IncFME2025-07-21
10842942013925PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014472PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014489PRIMEDpriMED Medical Products IncFME2025-07-21
10842942016087PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524427PRIMEDpriMED Medical Products IncFME2025-07-21
00840456201565JMUJMU DENTAL, INCFME2025-07-15
00840456201572JMUJMU DENTAL, INCFME2025-07-15
00840456201589JMUJMU DENTAL, INCFME2025-07-15
00840456201596JMUJMU DENTAL, INCFME2025-07-15
00840456201602JMUJMU DENTAL, INCFME2025-07-15
00840456201619JMUJMU DENTAL, INCFME2025-07-15
00840456201626JMUJMU DENTAL, INCFME2025-07-15
00840456201633JMUJMU DENTAL, INCFME2025-07-15
00840456201640JMUJMU DENTAL, INCFME2025-07-15
00840456201657JMUJMU DENTAL, INCFME2025-07-15
00840456201664JMUJMU DENTAL, INCFME2025-07-15
00840456201671JMUJMU DENTAL, INCFME2025-07-15