FDA UDI
In Commercial Distribution
🇺🇸 United States
QUALICARE
DI: 06959793314907
·
Model: Φ22mm
·
CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- QUALICARE
- Primary DI
- 06959793314907
- Version / Model
- Φ22mm
- Catalog Number
- QP7011
- Company Name
- CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD.
- Labeler DUNS
- 526892074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2025-09-18
- Public Version
- 1
- Public Version Date
- 2025-09-26
- Public Version Status
- New
- Public Device Record Key
- ff510bb0-031a-4f70-88b5-6a2d17306648
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 44990 | Skin-cover adhesive strip, non-antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16959793314904 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 06959793314907 | GS1 | ||||
| Unit of Use | 06959793316383 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 35 Degrees Celsius