FDA UDI
In Commercial Distribution
🇺🇸 United States
Calibration Gas
DI: 05700699621887
·
Model: 962-188
·
Radiometer Medical ApS
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Calibration Gas
- Primary DI
- 05700699621887
- Version / Model
- 962-188
- Catalog Number
- 962-188
- 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
- 2023-09-05
- Public Version Status
- Update
- Public Device Record Key
- 670c3ab9-1ce8-4e1d-962d-a574434ad9bf
Device Description
TCM4 CAL GAS
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
- Yes
- 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 |
|---|---|---|---|---|
| 65331 | Calibration gas/non-refillable cylinder | A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the proper gas type, concentration and/or quantity; it may in addition be used for testing a patient’s pulmonary function. This device is reusable until the contents of the container are exhausted. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699621887 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius