FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 30885380112410
·
Model: 8234641
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
218
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 30885380112410
- Version / Model
- 8234641
- Catalog Number
- 8234641
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 218
- Record Status
- Published
- Publish Date
- 2019-06-24
- Public Version
- 3
- Public Version Date
- 2021-06-30
- Public Version Status
- Update
- Public Device Record Key
- 7a60c5c6-5e54-4856-aeb3-d21833047f55
- Distribution End Date
- 2021-06-30
Device Description
CHART PAPER, CARDIAC SCIENCE 16211-002
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 |
|---|---|---|---|---|---|---|
| Package | 50885380112414 | GS1 | CASE | 10 | Not in Commercial Distribution | 2021-06-30 |
| Primary | 30885380112410 | GS1 | ||||
| Unit of Use | 10885380112416 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 280 | Millimeter | |
| Length | 216 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 65 Percent (%) Relative Humidity