FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVEOS Cuvette Arc Pack
DI: 00816879023114
·
Model: 117450-001
·
HYCOR BIOMEDICAL LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVEOS Cuvette Arc Pack
- Primary DI
- 00816879023114
- Version / Model
- 117450-001
- Company Name
- HYCOR BIOMEDICAL LLC
- Labeler DUNS
- 010558476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-11
- Public Version
- 1
- Public Version Date
- 2021-01-19
- Public Version Status
- New
- Public Device Record Key
- e46f04b0-a323-49cd-bc29-d5c5a6d04ce5
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
- No
- 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 |
|---|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | 866.5750 | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61298 | General laboratory assay tray | A tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or 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 |
|---|---|---|---|---|---|---|
| Primary | 00816879023114 | GS1 |
Customer Contacts
- Phone
- 800-382-2527
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182479 | 000 |