FDA UDI
In Commercial Distribution
🇺🇸 United States
Ceodeux S.A - Meditec
DI: 05400992002900
·
Model: M96600179 (old number) - 1106130 (new SAP number)
·
CEODEUX S.A.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ceodeux S.A - Meditec
- Primary DI
- 05400992002900
- Version / Model
- M96600179 (old number) - 1106130 (new SAP number)
- Catalog Number
- M966
- Company Name
- CEODEUX S.A.
- Labeler DUNS
- 400635868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-07
- Public Version
- 1
- Public Version Date
- 2023-11-15
- Public Version Status
- New
- Public Device Record Key
- 6040a9e5-218b-4e5e-95e7-876fd34f3286
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ECX | Cylinder, Compressed Gas, And Valve | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58754 | Nitric oxide refillable cylinder | A container designed as a refillable cylinder used to hold compressed nitric oxide (NO), also known as nitrogen monoxide, under safe conditions at high pressure. It is typically filled with NO when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote NO content. The cylinder is made of non-corrosive aluminium (Al) and must be used with a pressure regulator in order to release the NO at the correct working pressure. NO is used for severe respiratory problems in neonates, children, and adults, e.g., for treatment of primary pulmonary hypertension (PPH) and some surgical interventions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15400992002907 | GS1 | Cardboard box | 50 | In Commercial Distribution | |
| Primary | 05400992002900 | GS1 |