FDA UDI
In Commercial Distribution
🇺🇸 United States
TopCare health
DI: 00036800391437
·
Model: 036800391437
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- TopCare health
- Primary DI
- 00036800391437
- Version / Model
- 036800391437
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-13
- Public Version
- 3
- Public Version Date
- 2023-05-17
- Public Version Status
- Update
- Public Device Record Key
- b2743dd4-9215-44ee-9385-a6003e5ee66e
Device Description
First Aid Essentials First Aid Kit, 70 items including 1 carrying case: 6 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 4 - Antibiotic Ointments 0.03 OZ (0.9 g); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 1 - Carrying Case; 5 - Fabric Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 10 - Fabric Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 15 - Fabric Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 21 - Sheer Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LRR | First Aid Kit With Drug | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44039 | First aid kit, medicated | A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10036800391434 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 00036800391437 | GS1 | ||||
| Package | 10036800425986 | GS1 | tray | 15 | In Commercial Distribution | |
| Package | 20036800391431 | GS1 | case | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 18884230139
- [email protected]