FDA.reportPublic FDA data

Vitus

Primary DI
10850025153000
Brand
Vitus
Company
HR PHARMACEUTICALS INC.
Model
6050B
Catalog number
6050B
Device description
Vitus Skin Prep Wipe
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10850025153000PackageGS150In Commercial Distribution
50850025153008PackageGS124In Commercial Distribution
00850025153003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002515300010850025153000
5085002515300850850025153008
00850025153003008500251530038500251530030850025153003

GMDN Terms#

Term, Definition table
TermDefinition
Skin adhesive protective materialA liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828918164
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
00851809002425Surgilube2810205022810205022018-08-27
00851809002449Surgilube2810205362810205362018-08-27
00851809002852EcoVue2852852018-07-16
00850025153027Vitus5205202021-05-19
00850025153034Vitus5215212021-05-19
00850025153041Vitus5225222021-05-19
00850025153089Vitus5135132023-03-31
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

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
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
00810040134906Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08