FDA.reportPublic FDA data

BELL-HORN

Primary DI
00888912223447
Brand
BELL-HORN
Company
DJO, LLC
Model
11248M
Device description
ANTIEMB 18MMHG KN OT WHITE, M
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912223447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912223447008889122234478889122234470888912223447

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
081840873
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

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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
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00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22