FDA.reportPublic FDA data

BGEcare Anti-Embolism Stockings

Primary DI
06959385797330
Brand
BGEcare Anti-Embolism Stockings
Company
Zhende Medical Co., Ltd.
Model
BGE20023TOM
Device description
BGEcare Anti-Embolism Stockings Thigh High Open Toe Medium, White(1 Pair)
Published
2021-03-05
Public version status
New
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06959385797330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959385797330069593857973306959385797330

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654591569
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959385787003ZDLYRC1200012023-06-22
06942273317574ZDNUMT0062024-01-22
06942273317598ZDNUMT0052024-01-22
06942273317611ZDNUMT0082024-01-22
06942273317635ZDNUMT0072024-01-22
06942273317659ZDNUMT0022024-01-22
06942273317673ZDNUMT0012024-01-22
06942273317697ZDNUMT0042024-01-22
06942273317710ZDNUMT0032024-01-22
06942273317734ZDNUMT0092024-01-22
06942273317758ZDNUMT0112024-01-22
06942273317772ZDNUMT0102024-01-22
06942273317796ZDNUMT0132024-01-22
06942273317819ZDNUMT0122024-01-22
06942273317833ZDNUMT0152024-01-22
06942273317857ZDNUMT0142024-01-22
06942273317871ZDNUMT0162024-01-22
06942273317895ZDNUMT016S2024-01-22
06942273317918ZDNUMT0172024-01-22
06942273317932ZDNUMT017S2024-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.DWL2026-06-04