FDA.reportPublic FDA data

VenoTrain soft

Primary DI
04057532459086
Brand
VenoTrain soft
Company
Bauerfeind AG
Model
21263015100234
Published
2022-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
04057532459086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057532459086040575324590864057532459086

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 intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315914853
Device count
1
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
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
00048503515485Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515492Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515508Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515515Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515522Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515539Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515546Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515553Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00850073571385American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571392American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571415American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571422American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571446American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571453American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571477American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571484American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04