FDA UDI
In Commercial Distribution
🇺🇸 United States
BGEcare Elastic Bandage with Self-closure
DI: 06972403420003
·
Model: EB070205011206NS
·
Henan Zhende Medical Products Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BGEcare Elastic Bandage with Self-closure
- Primary DI
- 06972403420003
- Version / Model
- EB070205011206NS
- Company Name
- Henan Zhende Medical Products Co., Ltd.
- Labeler DUNS
- 544509489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 2
- Public Version Date
- 2021-09-20
- Public Version Status
- Update
- Public Device Record Key
- 804757f4-3072-4403-ad63-aa0f9df364f6
Device Description
BGEcare Elastic Bandage with Self-closure, 2in X 5 yards, 12 rolls/box, 6 boxes/carton box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06972403420010 | GS1 | carton box | 6 | In Commercial Distribution | |
| Primary | 06972403420003 | GS1 |