FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 30885632130186
·
Model: 69922
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 30885632130186
- Version / Model
- 69922
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 1
- Public Version Date
- 2020-10-07
- Public Version Status
- New
- Public Device Record Key
- 3fe2556a-f9a0-4b87-ac7f-423fbebb0cb7
Device Description
Warmer Heel Infant With Heel Strap Clear Liquid With Adhesive Band 3.5 X 5.5 Inch Not Made With Natural Rubber Latex MediChoice
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
- Yes
- 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 | 50885632130180 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 30885632130186 | GS1 | ||||
| Unit of Use | 10885632130182 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 14 – 140 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity