FDA UDI
In Commercial Distribution
🇺🇸 United States
N Evaporation Caps for Control Vials (2.5 mL)
DI: 00842768012297
·
Model: 10446534
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- N Evaporation Caps for Control Vials (2.5 mL)
- Primary DI
- 00842768012297
- Version / Model
- 10446534
- Catalog Number
- OVLC21
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-10-31
- Public Version
- 5
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 5ab56db6-a766-4dce-a4a9-39e6c27fcfaa
Device Description
The N Evaporation Cap 2.5ml is part of the BN ProSpec system.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JZW | NEPHELOMETER | Immunology | 866.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56728 | Nephelometry immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768012297 | GS1 | ||||
| Unit of Use | 00842768024795 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001647 | 000 |