FDA UDI
In Commercial Distribution
🇺🇸 United States
TCM4XX ETX Serial adapter, cable for TCM4XX ETX
DI: 05700696366491
·
Model: 636-649
·
Radiometer Medical ApS
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TCM4XX ETX Serial adapter, cable for TCM4XX ETX
- Primary DI
- 05700696366491
- Version / Model
- 636-649
- Catalog Number
- 636-649
- 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
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- 0984899c-e8cd-4d66-81a9-88c1df50d0ef
Device Description
TCM4XX ETX Serial adapter, cable for TCM4XX ETX
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 |
| LPP | Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia | Anesthesiology | 868.2500 | 2 |
| DPZ | Oximeter, ear | Cardiovascular | 870.2710 | 2 |
| KLK | Monitor, oxygen, cutaneous, for infant not under gas anesthesia | Anesthesiology | 868.2500 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700696366491 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]