FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 50885380019454
·
Model: 4762451
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 50885380019454
- Version / Model
- 4762451
- Catalog Number
- 4762451
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2019-06-24
- Public Version
- 1
- Public Version Date
- 2019-07-02
- Public Version Status
- New
- Public Device Record Key
- 331a24de-5a75-46c1-95c1-fda2d5f73b16
Device Description
CHART PAPER MARQUETTE 4305AAO, Z-FOLD
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
- 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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 50885380019454 | GS1 | ||||
| Unit of Use | 10885380019456 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- High: 35 Degrees Celsius