FDA UDI
In Commercial Distribution
🇺🇸 United States
American Red Cross
DI: B268Y7054Y70570
·
Model: Y7054, Y7057
·
TOMY INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- American Red Cross
- Primary DI
- B268Y7054Y70570
- Version / Model
- Y7054, Y7057
- Catalog Number
- Y7057
- Company Name
- TOMY INTERNATIONAL, INC.
- Labeler DUNS
- 065183758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-29
- Public Version
- 4
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- b7842ee2-253b-40aa-8fa3-8e8f8f1006fa
Device Description
Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
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 |
|---|---|---|---|---|---|---|
| Package | B268Y7054Y70579 | HIBCC | Master | 12 | In Commercial Distribution | |
| Package | B268Y7054Y70573 | HIBCC | Inner | 3 | In Commercial Distribution | |
| Package | B268Y7054Y70571 | HIBCC | Retail | 1 | In Commercial Distribution | |
| Primary | B268Y7054Y70570 | HIBCC |