FDA UDI
In Commercial Distribution
🇺🇸 United States
TCM4x Cable
DI: 05700699031815
·
Model: 903-181
·
Radiometer Medical ApS
Product Codes
5
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TCM4x Cable
- Primary DI
- 05700699031815
- Version / Model
- 903-181
- Catalog Number
- 903-181
- 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
- 3
- Public Version Date
- 2021-12-15
- Public Version Status
- Update
- Public Device Record Key
- c8a644c6-c83e-44bd-810f-e43a724e6cbf
Device Description
TCM4x Embletta gold interface cable
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
- No
- 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 |
| KLK | Monitor, oxygen, cutaneous, for infant not under gas anesthesia | Anesthesiology | 868.2500 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DPZ | Oximeter, ear | Cardiovascular | 870.2710 | 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 |
|---|---|---|---|---|
| 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 |
| 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 | 05700699031815 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]