FDA.reportPublic FDA data

VenoTrain look

Primary DI
04026358447232
Brand
VenoTrain look
Company
Bauerfeind AG
Model
21713021700321
Published
2016-10-02
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
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860826000VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSEBauerfeind GmbH & Co.1986-06-18DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026358447232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026358447232040263584472324026358447232

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for a hospitalized patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315914853
Device count
1
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026358026604VenoTrain soft212608100202222016-10-06
04026358026598VenoTrain soft212608100202212016-10-07
04026358026611VenoTrain soft212608100202232016-10-06
04046445989742VenoTrain soft212100142202312019-10-12
04026358440318VenoTrain micro218100153002212023-01-29
04026358440325VenoTrain micro218100153002222023-01-29
04046445257506VenoTrain micro218100153002232023-01-29
04046445257513VenoTrain micro218100153002242023-01-29
04046445257520VenoTrain micro218100153002312023-01-29
04046445257537VenoTrain micro218100153002322023-01-29
04046445257544VenoTrain micro218100153002332023-01-29
04046445257551VenoTrain micro218100153002342023-01-29
04046445257568VenoTrain micro218100153003212023-01-29
04046445257575VenoTrain micro218100153003222023-01-29
04046445257582VenoTrain micro218100153003232023-01-29
04046445257599VenoTrain micro218100153003242023-01-29
04046445257605VenoTrain micro218100153003312023-01-29
04046445257612VenoTrain micro218100153003322023-01-29
04046445257629VenoTrain micro218100153003332023-01-29
04046445257636VenoTrain micro218100153003342023-01-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810226440654ViveVIVE HEALTH LLCDWL2026-07-14
00810226440661ViveVIVE HEALTH LLCDWL2026-07-14
00810226440678ViveVIVE HEALTH LLCDWL2026-07-14
00810226440685ViveVIVE HEALTH LLCDWL2026-07-14
00810226440692ViveVIVE HEALTH LLCDWL2026-07-14
00810226440708ViveVIVE HEALTH LLCDWL2026-07-14
00810226440715ViveVIVE HEALTH LLCDWL2026-07-14
00810226440739ViveVIVE HEALTH LLCDWL2026-07-14
00810226440746ViveVIVE HEALTH LLCDWL2026-07-14
00810226440753ViveVIVE HEALTH LLCDWL2026-07-14
00810226440760ViveVIVE HEALTH LLCDWL2026-07-14
00810226440777ViveVIVE HEALTH LLCDWL2026-07-14
00810226440784ViveVIVE HEALTH LLCDWL2026-07-14
00810226440791ViveVIVE HEALTH LLCDWL2026-07-14
00810226440807ViveVIVE HEALTH LLCDWL2026-07-14
00810226440814ViveVIVE HEALTH LLCDWL2026-07-14
00810226440821ViveVIVE HEALTH LLCDWL2026-07-14
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
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00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22