BGE care

GUDID 06972403423110

Henan Zhende Medical Products Co., Ltd.

Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad
Primary Device ID06972403423110
NIH Device Record Key79bf0017-c2c1-44fd-9d4c-974c8e43520c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBGE care
Version Model NumberM14220C
Company DUNS544509489
Company NameHenan Zhende Medical Products Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972403423110 [Primary]

FDA Product Code

FRLFiber, Medical, Absorbent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-07
Device Publish Date2023-06-29

Devices Manufactured by Henan Zhende Medical Products Co., Ltd.

06972403423110 - BGE care2023-07-07
06972403423110 - BGE care2023-07-07
06972403420010 - BGEcare Elastic Bandage with Self-closure2021-03-16 BGEcare Elastic Bandage with Self-closure, 2in X 5 yards, 12 rolls/box, 6 boxes/carton box
06972403420034 - BGEcare Elastic Bandage with Self-closure2021-03-16 BGEcare Elastic Bandage with Self-closure, 4in X 5 yards, Latex Free,12 rolls/box, 6 boxes/carton box
06972403420058 - BGEcare Self Adhesive Non-woven Bandage2021-03-16 BGEcare Self Adhesive Non-woven Bandage, 2in X 5yards, 1 roll/OPP film, 36 rolls/box, 6 boxes/carton box
06972403420089 - BGEcare Self Adhesive Non-woven Bandage2021-03-16 BGEcare Self Adhesive Non-woven Bandage, 4in X 5yards, 1 roll/OPP film, 18 rolls/box, 6 boxes/carton box
06972403420119 - BGEcare Sterile Non-woven Sponge2021-03-16 BGEcare Sterile Non-woven Sponge 4"X4", 4-Ply, 2 pieces/pack, 35 packs/box, 20 boxes/carton box
06972403420140 - BGEcare Non-sterile Non-woven Sponge2021-03-16 BGEcare Non-sterile Non-woven Sponge 4"X4", 4-Ply, 200 pieces/pack, 10 packs/carton box
06972403420164 - BGEcare Non-sterile Non-woven Sponge2021-03-16 BGEcare Non-sterile Non-woven Sponge 3"X3", 4-Ply, 200 pieces/pack, 20 packs/carton box

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.