FDA.reportPublic FDA data

Halyard

Primary DI
90680651698042
Brand
Halyard
Company
O&M HALYARD, INC.
Model
69804
Catalog number
69804
Device description
Spunbond Bouffant Cap, L, Blue
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
FYFCAP, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651698040PrimaryGS10
90680651698042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065169804030680651698040
9068065169804290680651698042

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA non-sterile 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 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
500
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
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651718253Halyard71825718252020-11-16
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536901100BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901117BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901124BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901179BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
TQ26126151701Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
10810141933238VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933245VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933252VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933269VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933276VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933283VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933290VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933306VIVIT SupplyVivit Supply LLCFYF2024-11-29
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
20197344099945MedlineMEDLINE INDUSTRIES, INC.FYF2024-04-11
20197344036483MedlineMEDLINE INDUSTRIES, INC.FYF2023-12-19
30884389102590MedlineMEDLINE INDUSTRIES, INC.FYF2023-10-13