FDA UDI
In Commercial Distribution
🇺🇸 United States
GUANGYI
DI: 06974692681073
·
Model: PU type 10cm×12cm
·
Jiangsu Guangyi Medical Dressing Co.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GUANGYI
- Primary DI
- 06974692681073
- Version / Model
- PU type 10cm×12cm
- Company Name
- Jiangsu Guangyi Medical Dressing Co.,LTD.
- Labeler DUNS
- 526901056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-08
- Public Version
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- d68b1bb5-36fd-4aba-8ebf-e6af6d16c5c1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65042 | Percutaneous catheter infection protector, professional | A dressing-like device intended to be used by a healthcare professional to cover and protect a percutaneous access cannula/catheter site (typically intravenous) to manage and help prevent complications (e.g., leakage, bleeding, infection). It is available in a variety of designs which may include a foam pad intended to absorb exudates/blood and a transparent shield that allows observation, sometimes with holes for ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16974692681070 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 06974692681073 | GS1 |