FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica CI 1900 Dilution Cuvette
DI: 00630414304526
·
Model: 11099501
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atellica CI 1900 Dilution Cuvette
- Primary DI
- 00630414304526
- Version / Model
- 11099501
- Catalog Number
- 11099501
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-04
- Public Version
- 1
- Public Version Date
- 2023-08-14
- Public Version Status
- New
- Public Device Record Key
- 5e95a21f-24f4-4f88-a513-521cf890a36a
Device Description
Atellica CI 1900 Dilution Cuvette
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61033 | Laboratory analyser cuvette IVD, reusable | A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through sample and is typically made of plastic, glass or quartz with a flat base and an open top. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414304526 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222116 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius