FDA.reportPublic FDA data

BGEcare Elastic Bandage with Self-closure

Primary DI
06972403420034
Brand
BGEcare Elastic Bandage with Self-closure
Company
Henan Zhende Medical Products Co., Ltd.
Model
EB070405011206NS
Device description
BGEcare Elastic Bandage with Self-closure, 4in X 5 yards, Latex Free,12 rolls/box, 6 boxes/carton box
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
06972403420034PackageGS16In Commercial Distribution
06972403420027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403420034069724034200346972403420034
06972403420027069724034200276972403420027

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-supportive tube/strip, single-useAn elastic device intended to be worn over/around a limb (arm/leg) and/or finger to cover and support a dressing on a wound/injury (e.g., burn, postoperative, skin condition). It may be referred to as a dressing/bandage retainer and is either in the form of a generic tube (i.e., not a specific garment such as a sock, glove, vest, shorts, or hat) or gripping elastic strip made of synthetic material (e.g., nylon/elastane), and is available in various sizes for daily use in the home or healthcare facility. It may additionally be intended for use at other anatomical sites (where size is appropriate) however it is not dedicated to the abdomen/thorax. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544509489
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06972403420003BGEcare Elastic Bandage with Self-closureEB070205011206NS2021-03-08
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
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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