FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Medi-First Flexible Patch HW
DI: 00347682619732
·
Model: 61973
·
Medique Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medi-First Flexible Patch HW
- Primary DI
- 00347682619732
- Version / Model
- 61973
- Catalog Number
- 61973
- Company Name
- Medique Products
- Labeler DUNS
- 086911794
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-02
- Public Version
- 5
- Public Version Date
- 2020-08-07
- Public Version Status
- Update
- Public Device Record Key
- 09c81261-4aa4-445e-a13d-99aff99abdbd
- Distribution End Date
- 2019-09-02
Device Description
Flexible patch of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad intended to cover a superficial wound.
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
- No
- 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 | 50347682619737 | GS1 | master case | 24 | Not in Commercial Distribution | 2019-09-02 |
| Primary | 00347682619732 | GS1 |