FDA.reportPublic FDA data

BGEcare Self Adhesive Non-woven Bandage

Primary DI
06972403420041
Brand
BGEcare Self Adhesive Non-woven Bandage
Company
Henan Zhende Medical Products Co., Ltd.
Model
CB080205011806NS
Device description
BGEcare Self Adhesive Non-woven Bandage, 2in X 5yards, 1 roll/OPP film, 36 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
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
06972403420058PackageGS136In Commercial Distribution
06972403420065PackageGS16In Commercial Distribution
06972403420041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403420058069724034200586972403420058
06972403420065069724034200656972403420065
06972403420041069724034200416972403420041

GMDN Terms#

Term, Definition table
TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Regulatory Flags#

DUNS number
544509489
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
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10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
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