FDA UDI
In Commercial Distribution
🇺🇸 United States
Honeywell Safety Products USA, Inc.
DI: 00821812024523
·
Model: 018504-4222
·
North Safety de Mexicali, S. de R. L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Honeywell Safety Products USA, Inc.
- Primary DI
- 00821812024523
- Version / Model
- 018504-4222
- Company Name
- North Safety de Mexicali, S. de R. L. de C.V.
- Labeler DUNS
- 812503712
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-26
- Public Version
- 1
- Public Version Date
- 2020-10-05
- Public Version Status
- New
- Public Device Record Key
- 9930a060-c247-4d1c-a767-8fbb2a22d253
Device Description
First Aid Kit containing Medical Devices class I and Drugs OTC: Neomycin Antibiotic, Triangular Bandage, Rescue Blanket, Gauze Compress, Hydrocortisone, Plastic Tweezer, Adhesive Bandage, Antiseptic, Burn Relief, Adhesive Tape, Gauze Clean-wrap Bandage, Gauze Pads, CPR Filter Shield, PVP Pre pads, Buffered Eye Wash, Scissor Bandage, Nitrile gloves, Cold Pack, Eye Pads, Woven Fingertip Bandage, Woven Knuckle Bandage.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00821812024523 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 82 – 89 Degrees Fahrenheit