FDA UDI
In Commercial Distribution
🇺🇸 United States
First Aid Kit
DI: 08052691610008
·
Model: DIN-131642022-02
·
Tek Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- First Aid Kit
- Primary DI
- 08052691610008
- Version / Model
- DIN-131642022-02
- Company Name
- Tek Corporation
- Labeler DUNS
- 141817465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 1
- Public Version Date
- 2022-12-23
- Public Version Status
- New
- Public Device Record Key
- b91a8d44-db07-4cb9-8b15-f57c73d1aeaf
Device Description
First Aid Kit for car makers, to be placed into vehicles
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LRR | First Aid Kit With Drug | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12500 | Medical bag | A portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052691610008 | GS1 | ||||
| Package | 08052691610015 | GS1 | Bag | 1 | In Commercial Distribution | |
| Package | 08052691610022 | GS1 | Case | 1 | In Commercial Distribution | |
| Package | 08052691610039 | GS1 | Bag | 1 | In Commercial Distribution |