FDA.reportPublic FDA data

VenoTrain micro

Primary DI
04057532552244
Brand
VenoTrain micro
Company
Bauerfeind AG
Model
21870725300009
Published
2023-01-29
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
04057532552244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057532552244040575325522444057532552244

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.

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
04046445999505VenoTrain soft212648243002312021-07-21
04046445989759VenoTrain soft212100142202322019-10-12
04046445989797VenoTrain soft212100142203222019-10-12
04046445989803VenoTrain soft212100142203232019-10-12
04046445989810VenoTrain soft212100142203242019-10-12
04046445989827VenoTrain soft212100142203312019-10-12
04046445989834VenoTrain soft212100142203322019-10-12
04046445989858VenoTrain soft212100142203342019-10-12
04057532013318VenoTrain soft212708142800092019-10-11
04057532013622VenoTrain soft212706142900092019-10-11
04046445000003VenoTrain soft212800142202332018-06-23
04046445000010VenoTrain soft212800142202342018-06-23
04046445000027VenoTrain soft212800142203212018-06-23
04046445000126VenoTrain soft212800143002232018-06-23
04046445000133VenoTrain soft212800143002242018-06-23
04046445000140VenoTrain soft212800143002312018-06-23
04046445000164VenoTrain soft212800143002332018-06-23
04046445000171VenoTrain soft212800143002342018-06-23
04046445000249VenoTrain soft212800143003332018-06-23
04046445000256VenoTrain soft212800143003342018-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026358026697VenoTrain softBauerfeind AGDWL2016-10-07
04026358026703VenoTrain softBauerfeind AGDWL2016-10-07
04026358026710VenoTrain softBauerfeind AGDWL2016-10-07
04026358026727VenoTrain softBauerfeind AGDWL2016-10-07
04026358026741VenoTrain softBauerfeind AGDWL2016-10-07
04026358026857VenoTrain softBauerfeind AGDWL2016-10-07
04026358026871VenoTrain softBauerfeind AGDWL2016-10-07
04026358026888VenoTrain softBauerfeind AGDWL2016-10-07
04026358027298VenoTrain softBauerfeind AGDWL2016-10-07
04026358027304VenoTrain softBauerfeind AGDWL2016-10-07
04026358027359VenoTrain softBauerfeind AGDWL2016-10-07
04026358027366VenoTrain softBauerfeind AGDWL2016-10-07
04026358027434VenoTrain softBauerfeind AGDWL2016-10-07
04026358027441VenoTrain softBauerfeind AGDWL2016-10-07
04026358027458VenoTrain softBauerfeind AGDWL2016-10-07
04026358027465VenoTrain softBauerfeind AGDWL2016-10-07
04026358027595VenoTrain softBauerfeind AGDWL2016-10-07
04026358027762VenoTrain softBauerfeind AGDWL2016-10-07
04026358027830VenoTrain softBauerfeind AGDWL2016-10-07
04026358027854VenoTrain softBauerfeind AGDWL2016-10-07
04026358026598VenoTrain softBauerfeind AGDWL2016-10-07
04026358026666VenoTrain softBauerfeind AGDWL2016-10-07
04026358026680VenoTrain softBauerfeind AGDWL2016-10-07
04026358026734VenoTrain softBauerfeind AGDWL2016-10-07
04026358026840VenoTrain softBauerfeind AGDWL2016-10-07
04026358027274VenoTrain softBauerfeind AGDWL2016-10-07
04026358027281VenoTrain softBauerfeind AGDWL2016-10-07
04026358027373VenoTrain softBauerfeind AGDWL2016-10-07
04026358027380VenoTrain softBauerfeind AGDWL2016-10-07
04026358027519VenoTrain softBauerfeind AGDWL2016-10-07