FDA.reportPublic FDA data

Halyard

Primary DI
20885632431187
Brand
Halyard
Company
O&M HALYARD, INC.
Model
55645
Catalog number
55645
Device description
HALYARD* Lubricating Deodorant Clear Unscented 8 oz.
Published
2024-11-12
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
GDSBag, stomal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDSBag, StomalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632431187PackageGS112In Commercial Distribution
10885632431180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563243118720885632431187
1088563243118010885632431180

GMDN Terms#

Term, Definition table
TermDefinition
Peristomal/periwound dressingA non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
1
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
true
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
30680651424465Halyard42446NS42446NS2026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898616351431OstomyGelDMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDAGDS2025-04-28
10885632431173HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431180HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431197HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431170HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431194HalyardO&M HALYARD, INC.GDS2024-11-12
00610075097722HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097753HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097777HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097726HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097757HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097771HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00618029980274Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
50618029980279Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
10610075097729HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097750HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097774HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049367HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049459HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049497HollisterHOLLISTER INCORPORATEDGDS2022-12-01
00610075097739HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097760HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097784HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097733HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097764HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097788HollisterHOLLISTER INCORPORATEDGDS2022-09-21