FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTROL LIQUID, OXICOM - High vial
DI: B154O0034091HIG00
·
Model: CONTROL LIQUID, OXICOM - High vial
·
WATERS MEDICAL SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CONTROL LIQUID, OXICOM - High vial
- Primary DI
- B154O0034091HIG00
- Version / Model
- CONTROL LIQUID, OXICOM - High vial
- Catalog Number
- 0034091.000
- Company Name
- WATERS MEDICAL SYSTEMS, LLC
- Labeler DUNS
- 556957871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-12
- Public Version
- 3
- Public Version Date
- 2019-03-21
- Public Version Status
- Update
- Public Device Record Key
- 3e7f6039-26ba-402b-a8a1-f695b997dc85
Device Description
Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range.
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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15200 | Intracardiac oximeter | A mains electricity (AC-powered) photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation. It is typically used in conjunction with a fibreoptic oximeter catheter (e.g., a Swan-Ganz catheter) that is introduced via a vein in the groin or neck to measure mixed venous oxygen saturation (SvO2) or evaluate intracardiac shunts. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B154O0034091HIG00 | HIBCC |
Customer Contacts
- Phone
- 507-288-7777
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius