FDA.reportPublic FDA data

BGEcare Elastic Bandage with Self-closure

Primary DI
06972403420003
Brand
BGEcare Elastic Bandage with Self-closure
Company
Henan Zhende Medical Products Co., Ltd.
Model
EB070205011206NS
Device description
BGEcare Elastic Bandage with Self-closure, 2in X 5 yards, 12 rolls/box, 6 boxes/carton box
Published
2021-03-08
Public version status
Update
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
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972403420010PackageGS16In Commercial Distribution
06972403420003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403420010069724034200106972403420010
06972403420003069724034200036972403420003

GMDN Terms#

Term, Definition table
TermDefinition
Skin treatment/dressing-supportive limb/finger bandage, single-useAn elastic, tubular device intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury; it is not designed for tissue support/compression. It is typically made of non-allergenic natural materials or a composite (e.g., viscose/nylon/elastane), and intended for use in the home and healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
544509489
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972403420102BGEcare Sterile Non-woven SpongeNS06040404023520S2021-03-08
06972403420171BGEcare Sterile Non-woven SpongeNS06030304025024S2021-03-08
06972403420225BGEcare Sterile Non-woven SpongeNS06020204025030S2021-03-08
06972403420256BGEcare Sterile Non-woven SpongeNS09020206023520S2021-03-08
06972403420287BGEcare Sterile Non-woven SpongeNS09040406022512S2021-03-08
06972403423110BGE careM14220C2023-06-29
06972403420027BGEcare Elastic Bandage with Self-closureEB070405011206NS2021-03-08
06972403420041BGEcare Self Adhesive Non-woven BandageCB080205011806NS2021-03-08
06972403420072BGEcare Self Adhesive Non-woven BandageCB080405011806NS2021-03-08
06972403420133BGEcare Non-sterile Non-woven SpongeNS0604040420010NS2021-03-08
06972403420157BGEcare Non-sterile Non-woven SpongeNS0603030420020NS2021-03-08
06972403420201BGEcare Non-sterile Non-woven SpongeNS0602020420020NS2021-03-08
06972403420010BGEcare Elastic Bandage with Self-closureEB070205011206NS2021-03-08
06972403420034BGEcare Elastic Bandage with Self-closureEB070405011206NS2021-03-08
06972403420058BGEcare Self Adhesive Non-woven BandageCB080205011806NS2021-03-08
06972403420089BGEcare Self Adhesive Non-woven BandageCB080405011806NS2021-03-08
06972403420119BGEcare Sterile Non-woven SpongeNS06040404023520S2021-03-08
06972403420140BGEcare Non-sterile Non-woven SpongeNS0604040420010NS2021-03-08
06972403420164BGEcare Non-sterile Non-woven SpongeNS0603030420020NS2021-03-08
06972403420188BGEcare Sterile Non-woven SpongeNS06030304025024S2021-03-08

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Primary DI, Brand, Company table
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10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
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