FDA.reportPublic FDA data

Vitus

Primary DI
00850025153027
Brand
Vitus
Company
HR PHARMACEUTICALS INC.
Model
520
Catalog number
520
Device description
"Vitus 2"" Seal Thin"
Published
2021-05-19
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
10850025153024PackageGS120In Commercial Distribution
50850025153022PackageGS1400In Commercial Distribution
00850025153027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002515302410850025153024
5085002515302250850025153022
00850025153027008500251530278500251530270850025153027

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067913238SteriGear®101362026-10-16
00850067913245SteriGear®101532026-10-16
00850067913252SteriGear®101542026-10-16
00850067913269SteriGear®102042026-10-16
00850067913276SteriGear®102242026-10-16
00850067913283SteriGear®102472026-10-16
00850067913054Fig Leaf®102732026-10-15
00850067913061Fig Leaf®102802026-10-15
00850067913078Fig Leaf®102862026-10-15
00850067913085SteriGear®101002026-10-15
00850067913092SteriGear®101012026-10-15
00850067913108SteriGear®101022026-10-15
00850067913115SteriGear®101072026-10-15
00850067913122SteriGear®101082026-10-15
00850067913139SteriGear®101092026-10-15
00850067913146SteriGear®101102026-10-15
00850067913153SteriGear®101112026-10-15
00850067913160SteriGear®101122026-10-15
00850067913177SteriGear®101192026-10-15
00850067913184SteriGear®101252026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088144574CARBOUNingbo kehu Medical Technology Co.,Ltd.EZS2026-07-09
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
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