FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632115875
·
Model: CP4305CA
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632115875
- Version / Model
- CP4305CA
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-28
- Public Version
- 1
- Public Version Date
- 2020-10-06
- Public Version Status
- New
- Public Device Record Key
- 36de198e-bf6e-4a2b-8a19-5fc172e3a061
Device Description
Chart Paper Ekg Fetal W/chart Wraps & Labels Z-fold Red Grid 152mm x90mm Disposable/sngle Use Latex Free Non Sterile MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DSF | RECORDER, PAPER CHART | Cardiovascular | 870.2810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61901 | Medical printer paper | A thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by a medical device (e.g., laboratory instrument/analyser, electrocardiograph, x-ray imaging system, hospital printer). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632115873 | GS1 | 80 | In Commercial Distribution | ||
| Primary | 10885632115875 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 65 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Type
- Handling Environment Temperature
- Temperature Range
- 35 – 100 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight or place into contact with or near carbon paper, carbonless forms, adhesives, adhesive tapes, solvents or plastics such as page protectors, dividers or folders.