FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380155434
·
Model: CH110711
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380155434
- Version / Model
- CH110711
- Catalog Number
- CH110711
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2019-04-17
- Public Version
- 4
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 02cb1be1-a254-4efe-a9b8-083aedc7bc9a
Device Description
Sample Cup 0.25 ml Multi Analyzer
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46237 | General laboratory container, single-use | A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380155435 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 20885380155434 | GS1 | ||||
| Unit of Use | 10885380155437 | GS1 |