FDA UDI
In Commercial Distribution
🇺🇸 United States
The First Years
DI: B268Y7057A51
·
Model: Y7057A5
·
TOMY INTERNATIONAL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- The First Years
- Primary DI
- B268Y7057A51
- Version / Model
- Y7057A5
- Catalog Number
- Y7057A5
- Company Name
- TOMY INTERNATIONAL, INC.
- Labeler DUNS
- 065183758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-12
- Public Version
- 1
- Public Version Date
- 2024-01-22
- Public Version Status
- New
- Public Device Record Key
- f8bf92ac-7069-408f-9e38-86f980ca365f
Device Description
Health and Grooming Kit
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10243 | Infant care kit | A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B268Y7057A51 | HIBCC | ||||
| Package | B268Y7057A53 | HIBCC | Inner Carton | 3 | In Commercial Distribution | |
| Package | B268Y7057A59 | HIBCC | Master Carton | 12 | In Commercial Distribution |