FDA.reportPublic FDA data

Provox FlexiDerm Round (3pcs)

Primary DI
07331791010309
Brand
Provox FlexiDerm Round (3pcs)
Company
Atos Medical AB
Model
8234
Catalog number
8234
Device description
The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
Published
2022-12-08
Public version status
Update
Distribution status
Not 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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791010309PrimaryGS10
07331791016448Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791010309073317910103097331791010309
07331791016448073317910164487331791016448

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) 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius42 Degrees Celsius
Handling Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry, Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
355470923
Device count
3
Premarket exempt
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
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17