FDA.reportPublic FDA data

Bantex

Primary DI
07500463968358
Brand
Bantex
Company
Solomed, S.A. de C.V.
Model
6cm
Device description
Rubber Band Smarch
Published
2019-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07500463968358PrimaryGS10
17500463968355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07500463968358075004639683587500463968358
1750046396835517500463968355

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, Hevea-latex, single-use, non-sterileA non-sterile strip or roll made of fabric with Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
588625921
Device count
5
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
07500463968341Sterilex1000ml2019-05-30
07500463968396FlexmarSmall2019-07-26
07502286510004FlexmarLarge2019-07-26
07502286510011Hidroderm 10 x 10 cm2019-07-26
07502286510028Hidroderm 15 x 16 cm2019-07-26
07502286510035Hidroderm 15 x 21 cm2019-07-26
07502286510042SOLOMED Disposable Surgical GownMedium Size 2020-07-17
07502286510059SOLOMED Disposable Surgical GownLarge Size2020-07-17
07502286510066SOLOMED Disposable Surgical GownExtra Large Size2020-07-17
17502286510049Bata quirúrgica SOLOMEDTalla mediana2020-07-17
17502286510056Bata quirúrgica SOLOMEDTalla grande2020-07-17
17502286510063Bata quirúrgica SOLOMEDTalla extra grande2020-07-17
07500463968372Pleura Med Adult2019-05-30
07500463968389Pleura MedPediatric 2019-05-30
07500463968303Osto System Adult2019-05-30
07500463968310Osto SystemPediatric 2019-05-30
07500463968327Osto SystemNeonatal 2019-05-30
07500463968334Osto System Adult2019-05-30
07500463968365Bantex8cm2019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440487ViveVIVE HEALTH LLCMHW2026-07-13
00810226440494ViveVIVE HEALTH LLCMHW2026-07-13
00810226440500ViveVIVE HEALTH LLCMHW2026-07-13
00810226440517ViveVIVE HEALTH LLCMHW2026-07-13
00810226440524ViveVIVE HEALTH LLCMHW2026-07-13
00810226440531ViveVIVE HEALTH LLCMHW2026-07-13
00810226440548ViveVIVE HEALTH LLCMHW2026-07-13
00810226440555ViveVIVE HEALTH LLCMHW2026-07-13
00810226440562ViveVIVE HEALTH LLCMHW2026-07-13
00810226440579ViveVIVE HEALTH LLCMHW2026-07-13
M68932700080BATTLE BANDAGESafeguard US Operating, LLCMHW2025-08-01
10884450828752SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-07-01
10884450844240SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-03-07
M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
00810041983572ViveVIVE HEALTH LLCMHW2024-06-07
00810041983589ViveVIVE HEALTH LLCMHW2024-06-07
00810041983596ViveVIVE HEALTH LLCMHW2024-06-07
00810041983602ViveVIVE HEALTH LLCMHW2024-06-07
00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
00840117327726"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green"Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
00810113571256ViveVIVE HEALTH LLCMHW2023-08-07
00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
00810113571966ViveVIVE HEALTH LLCMHW2023-08-07
00810113571973ViveVIVE HEALTH LLCMHW2023-08-07