FDA UDI
In Commercial Distribution
🇺🇸 United States
TOSCA Fixation rings (60x)
DI: 05700693096179
·
Model: 5601500
·
Radiometer Medical ApS
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
Basic Information
- Brand Name
- TOSCA Fixation rings (60x)
- Primary DI
- 05700693096179
- Version / Model
- 5601500
- Catalog Number
- 5601500
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2021-12-15
- Public Version Status
- Update
- Public Device Record Key
- 309bfaf0-3b22-44c4-8282-253b43b27278
Device Description
TOSCA Fixation rings (60x)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
| 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 |
| LKD | MONITOR, CARBON-DIOXIDE, CUTANEOUS | Anesthesiology | 868.2480 | 2 |
| DPZ | Oximeter, ear | Cardiovascular | 870.2710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46934 | Transcutaneous blood gas monitoring system | An assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700693096179 | GS1 | ||||
| Unit of Use | 55700693096174 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius