FDA.reportPublic FDA data

Provox Wipes

Primary DI
07331791010392
Brand
Provox Wipes
Company
Atos Medical AB
Model
8243
Catalog number
8243
Device description
Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives. Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue.
Published
2022-11-24
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
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791017247PackageGS150In Commercial Distribution
07331791010392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791017247073317910172477331791017247
07331791010392073317910103927331791010392

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic-polymer liquid barrier dressing, non-sterileA non-sterile liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU.
Special Storage Condition, Specify00Keep dry. Keep away from sunlight
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags#

DUNS number
355470923
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331791008320HME DigiTop O2775677562022-12-07
07331791015564Provox Life Coming Home USA8224US218224US212022-11-29
07331791001611Provox Adhesive FlexiDerm Round725372532022-07-13
07331791001628Provox Adhesive FlexiDerm Oval725472542022-07-13
07331791001635Provox Adhesive OptiDerm Round725572552022-07-13
07331791001642Provox Adhesive OptiDerm Oval725672562022-07-13
07331791001703Provox XtraBase Adhesive726572652022-07-13
07331791008016Provox StabiliBase (15 pcs)728972892022-07-13
07331791008160Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791008177Provox Adhesive OptiDerm Plus733273322022-07-13
07331791009037Provox StabiliBase OptiDerm (15 pcs)731873182022-07-13
07331791009259Provox Luna Adhesive801480142022-07-13
07331791009303Provox FreeHands Support Adhesive (15 pcs)802480242022-07-13
07331791009525Provox Adhesive Strip801580152022-07-13
07331791014420Provox Life Standard Adhesive Round746074602022-07-13
07331791014437Provox Life Standard Adhesive Oval746174612022-07-13
07331791014444Provox Life Standard Adhesive Plus746274622022-07-13
07331791014451Provox Life Sensitive Adhesive Round746374632022-07-13
07331791014468Provox Life Sensitive Adhesive Oval746474642022-07-13
07331791014475Provox Life Sensitive Adhesive Oval B746574652022-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16958868743069BiokerzonRoosin Medical Co., Ltd.NEC2026-04-27
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
20885632460309HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042128MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
40197344042129MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
10197344042104MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
10197344138906MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344042101MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344138903MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
00500223504328NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00500223504335NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00616784345512Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345611Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345413Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345314Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345437Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17