FDA UDI
In Commercial Distribution
🇺🇸 United States
TCM TOSCA module
DI: 05700699030443
·
Model: 903-044
·
Radiometer Medical ApS
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TCM TOSCA module
- Primary DI
- 05700699030443
- Version / Model
- 903-044
- Catalog Number
- 903-044
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- bc2d0f93-2a39-4298-a447-cb4f69bbbc8d
Device Description
TCM TOSCA module
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| LKD | MONITOR, CARBON-DIOXIDE, CUTANEOUS | Anesthesiology | 868.2480 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DPZ | Oximeter, ear | Cardiovascular | 870.2710 | 2 |
| KLK | Monitor, oxygen, cutaneous, for infant not under gas anesthesia | Anesthesiology | 868.2500 | 2 |
| LPP | Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia | Anesthesiology | 868.2500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37178 | Transcutaneous blood gas monitor sensor | A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699030443 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal