FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-
DI: 00630414596518
·
Model: 11099315
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-
- Primary DI
- 00630414596518
- Version / Model
- 11099315
- Catalog Number
- 11099315
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 5
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- c8922976-58cf-4901-9fde-b020e57cbc8d
Device Description
A-LYTE™ IMT (Na K Cl) Atellica CH - RGT
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 |
|---|---|---|---|---|
| JFL | PH RATE MEASUREMENT, CARBON-DIOXIDE | Clinical Chemistry | 862.1160 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52866 | Multiple electrolyte IVD, kit, ion-selective electrode (ISE) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414596518 | GS1 | ||||
| Unit of Use | 00630414006833 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151767 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius