FDA.reportPublic FDA data

Halyard

Primary DI
30680651473234
Brand
Halyard
Company
O&M HALYARD, INC.
Model
47323
Catalog number
47323
Device description
Spunbound Bouffant Cap, XL, Red
Published
2020-11-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYFCAP, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651473234PackageGS15In Commercial Distribution
20680651473237PrimaryGS10
90680651473236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147323430680651473234
2068065147323720680651473237
9068065147323690680651473236

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
100
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
true
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
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30197344202212MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
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06979032640086GOBENHUZHOU JUNDA INDUSTRY CO., LTD.FYF2025-08-26
10813360021519ProtexerICP MEDICAL, LLCFYF2025-08-19
00810184641346GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641353GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641360GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641377GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641384GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184642442GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859211GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859877GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859129GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
00850061859143GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
10827989003641Health Care Logistics, Inc®Health Care Logistics, Inc.FYF2025-04-22
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TQ26126152000Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
20810141933235VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933242VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933259VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933266VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933273VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933280VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933297VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933303VIVIT SupplyVivit Supply LLCFYF2024-11-29
14719882252522CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252546CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252560CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252584CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06