FDA UDI
In Commercial Distribution
🇺🇸 United States
MedSource Sampling Cannula
DI: 00840155413122
·
Model: MS-35400A14
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MedSource Sampling Cannula
- Primary DI
- 00840155413122
- Version / Model
- MS-35400A14
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-24
- Public Version
- 3
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- a1d0e68e-b63b-4925-aeb0-07bd6a5560f3
Device Description
14’ Adult Nasal CO2 Sampling Cannula
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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64429 | Carbon dioxide breath analyser, home-use | An electrically-powered device intended to be used in a clinical setting and in the home to measure the concentration of exhaled carbon dioxide (CO2) in normal tidal breathing, using a particular method (e.g., infrared spectroscopy, gas chromatography), and to telemetrically send data to a remote server and/or local computer/tablet for viewing results and clinical evaluation by a healthcare professional. It consists of a hand-held sensor unit and might in addition include a replaceable breath sampling chamber and a breathing mouthpiece. It is used to help identify or assess cardio-respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, chronic heart failure). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840155413139 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00840155413122 | GS1 | ||||
| Package | 00840155413146 | GS1 | Case | 200 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143127 | 000 |