FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TINY TOES
DI: 20885380044844
·
Model: 11470-010T
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- TINY TOES
- Primary DI
- 20885380044844
- Version / Model
- 11470-010T
- Catalog Number
- 11470-010T
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-09-30
- Public Version
- 3
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- d22d511f-b0aa-4e1f-9f6f-0d21b0918e26
- Distribution End Date
- 2022-12-10
Device Description
INFANT HEEL WARMER DISC, 3.75X5.5IN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IMD | PACK, HOT OR COLD, DISPOSABLE | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37697 | Exothermic heat therapy pack/patch | A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380044845 | GS1 | CASE | 4 | Not in Commercial Distribution | 2022-12-10 |
| Primary | 20885380044844 | GS1 | ||||
| Unit of Use | 10885380044847 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity