FDA.reportPublic FDA data

Halyard

Primary DI
10885632431180
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
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.

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17
30680651496974Halyard49697496972025-05-17
30680651496981Halyard49698496982025-05-17
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04

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
10885632431197HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431170HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431187HalyardO&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