AccessGUDID - DEVICE: BGEcare Elastic Bandage with Self-closure (06972403420003)

GUDID

Device Identifier (DI) Information

Brand Name: BGEcare Elastic Bandage with Self-closure
Version or Model: EB070205011206NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Henan Zhende Medical Products Co., Ltd.

Primary DI Number: 06972403420003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544509489 *Terms of Use

Device Description: BGEcare Elastic Bandage with Self-closure, 2in X 5 yards, 12 rolls/box, 6 boxes/carton box

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13369	Skin treatment/dressing-supportive limb/finger bandage, single-use	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 804757f4-3072-4403-ad63-aa0f9df364f6
Public Version Date: September 20, 2021
Public Version Number: 2
DI Record Publish Date: March 08, 2021