FDA UDI
In Commercial Distribution
🇺🇸 United States
CO2 Adult Nasal Line
DI: EMIP54000421
·
Model: CO2 Adult Nasal Line
·
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- CO2 Adult Nasal Line
- Primary DI
- EMIP54000421
- Version / Model
- CO2 Adult Nasal Line
- Catalog Number
- 5400042
- Company Name
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Labeler DUNS
- 324416379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-11-11
- Public Version
- 2
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- e43e1f75-77c2-4918-908d-9445c96d8d34
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EMIP54000421 | HIBCC | ||||
| Unit of Use | EMIP54000420 | HIBCC |
Customer Contacts
- Phone
- +49814592090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142032 | 000 |