FDA.reportPublic FDA data

VenoTrain micro

Primary DI
04046445260421
Brand
VenoTrain micro
Company
Bauerfeind AG
Model
21813025300233
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
04046445260421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046445260421040464452604214046445260421

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
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
00674854000013SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000235SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000242SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000259SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000266SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000273SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000280SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000297SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000303SOFT SOCK ®Thuasne LLCDWL2018-12-31
00674854000310SOFT SOCK ®Thuasne LLCDWL2018-12-31