FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable CO2 Cuvette paed.
DI: 04048675421597
·
Model: MP01063
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable CO2 Cuvette paed.
- Primary DI
- 04048675421597
- Version / Model
- MP01063
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-17
- Public Version
- 2
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- 722fac65-4ac5-4c60-8771-9f4d5221f79d
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46821 | Carbon dioxide cuvette, single-use | A non-electrical device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor [not included] that is slotted over the outside of the window section; some types may additionally feature an adaptor for the acceptance of a gas flow sensor. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048675421597 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100941 | 000 |