FDA UDI
In Commercial Distribution
🇺🇸 United States
Ready Sensor™ Lactate Biosensor
DI: 00630414112350
·
Model: 10311032
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Ready Sensor™ Lactate Biosensor
- Primary DI
- 00630414112350
- Version / Model
- 10311032
- Catalog Number
- 476379
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- 243aa664-7732-4c13-8537-d3581b0abbe6
Device Description
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
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
- Yes
- 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 |
|---|---|---|---|---|
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | Clinical Chemistry | 862.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30208 | Lactate electrode IVD | An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of lactate ions in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414112350 | GS1 | ||||
| Unit of Use | 00630414009278 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K934907 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius