FDA.reportPublic FDA data

Vitus

Primary DI
00850025153089
Brand
Vitus
Company
HR PHARMACEUTICALS INC.
Model
513
Catalog number
513
Device description
Vitus 1/3 Crescent Barrier Ext
Published
2023-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZSAPPLIANCE, COLOSTOMY, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZSAppliance, Colostomy, DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850025153086PackageGS130In Commercial Distribution
50850025153084PackageGS150In Commercial Distribution
00850025153089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002515308610850025153086
5085002515308450850025153084
00850025153089008500251530898500251530890850025153089

GMDN Terms#

Term, Definition table
TermDefinition
Removable ambulatory appliance skin-adherent patchA patch with a pressure-sensitive adhesive coating designed to be adhered to the skin to temporarily secure/affix a removable patient-worn ambulatory appliance [e.g., tracheostomy base plate, insulin infusion pump, implantable pulse generator (IPG) battery charger] to the body. It is made of synthetic polymer materials [e.g., polyurethane] and is available in various designs (e.g., round, slot, spiral, with a central opening to fit the wearable appliance). It is not intended to adhere an external aesthetic restoration prosthesis (e.g., artificial nose, breast prosthesis) to the skin surface. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrpharma.com

Regulatory Flags#

DUNS number
828918164
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851809002425Surgilube2810205022810205022018-08-27
00851809002449Surgilube2810205362810205362018-08-27
00851809002852EcoVue2852852018-07-16
00850025153027Vitus5205202021-05-19
00850025153034Vitus5215212021-05-19
00850025153041Vitus5225222021-05-19
00850058254333TruLockTLFC12025-03-03
00850058254364TruLockTLFC52025-03-03
00850058254371TruLockTLFCP2025-03-03
00850067913009TruLockTLFS302026-03-06
00850067913016TruLockTLFS562026-03-06
00850058254579LivLIV082026-03-30
00850058254586LivLIV102026-03-30
00850058254593LivLIV122026-03-30
00850058254609LivLiv142026-03-30
00850025153188MTG32108321082022-09-28
00850025153195MTG32110321102022-09-28
00850025153218MTG32112321122022-09-28
00850025153232MTG32114321142022-09-28
00851809002005HR Ultrasound Jelly212ST212ST2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10661613525006UltraMaxMarlen Manufacturing And Development Co.EZS2026-04-28
30885632431160HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431207HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431214HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431245HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431163HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431200HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431217HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431248HalyardO&M HALYARD, INC.EZS2025-01-10
00860010269800OstohOstoh, LLCEZS2024-12-16
10885632431128HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431135HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431142HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431159HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431227HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431234HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434709HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434716HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431122HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431132HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431149HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431153HalyardO&M HALYARD, INC.EZS2024-11-12
10810040134804Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
10810040134828Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134777Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134784Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134807Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134821Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134876Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134883Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08