FDA.reportPublic FDA data

Maxtaping

Primary DI
00840270627664
Brand
Maxtaping
Company
Oppo Medical Inc.
Model
8194-RD-F
Catalog number
8194
Device description
Maxtaping, 50mm Width x 4m Length/ 6 Rolls
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KOXSolvent, Adhesive Tape

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOXSolvent, Adhesive TapeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840270627664PrimaryGS10
00840270600865Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840270627664008402706276648402706276640840270627664
00840270600865008402706008658402706008650840270600865

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Please store at room temperature. Avoid sunlight and/or exposure to excessive heat or moisture.

Regulatory Flags#

DUNS number
830140807
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840270610062Maxtaping8007-BU-F80072025-04-01
00840270610369Maxtaping8080-BU-F80802025-04-01
00840270610512Maxtaping8007-BU-F80072025-04-01
00840270610529Maxtaping8080-BU-F80802025-04-01
00840270627466Maxtaping A+8095-BG-S80952022-12-01
00840270627473Maxtaping A+8095-BG-M80952022-12-01
00840270627480Maxtaping A+8095-BG-L80952022-12-01
00840270627497Maxtaping A+8095-PK-S80952022-12-01
00840270627503Maxtaping A+8095-PK-M80952022-12-01
00840270627510Maxtaping A+8095-PK-L80952022-12-01
00840270627527Maxtaping A+8095-BU-S80952022-12-01
00840270627534Maxtaping A+8095-BU-M80952022-12-01
00840270627541Maxtaping A+8095-BU-L80952022-12-01
00840270627626Maxtaping8194-BG-F81942022-12-01
00840270627633Maxtaping8194-BK-F81942022-12-01
00840270627640Maxtaping8194-BU-F81942022-12-01
00840270627657Maxtaping8194-YW-F81942022-12-01
00840270627671Maxtaping A+8195-BG-S81952022-12-01
00840270627688Maxtaping A+8195-BG-M81952022-12-01
00840270627695Maxtaping A+8195-BG-L81952022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344179811MEDLINEMEDLINE INDUSTRIES, INC.KOX2026-05-15
08904428744992OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428798469OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
307073877738793M™3M COMPANYKOX2026-02-19
007073875674603M™3M COMPANYKOX2026-02-19
507073875674653M™3M COMPANYKOX2026-02-19
507073877738733M™3M COMPANYKOX2026-02-19
30080196771763MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
40080196771760MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
00840270610062MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610369MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610512MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610529MaxtapingOppo Medical Inc.KOX2025-04-01
06950715505625cofoeCofoe Medical Technology Co.,LtdKOX2024-12-09
00810113577784ViveCareVIVE HEALTH LLCKOX2024-09-04
00810113577791ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577781ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577798ViveCareVIVE HEALTH LLCKOX2024-09-04
10193489131550MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
20193489131557MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
00810049490676Skinister MedicalDelta Molding LLCKOX2024-05-14
00810049490706Skinister MedicalDelta Molding LLCKOX2024-05-14
10884521738362ANS MEDICALCardinal Health, Inc.KOX2023-05-17
60884521738367ANS MEDICALCardinal Health, Inc.KOX2023-05-17
00850048477063WarriorNPWarriornp LLCKOX2023-03-03
00815991024771BodyMedBOXOUT, LLCKOX2023-02-17
00749756877978DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
00749756877985DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02