FDA UDI
In Commercial Distribution
🇺🇸 United States
SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE
DI: 05030267159789
·
Model: 1144015
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE
- Primary DI
- 05030267159789
- Version / Model
- 1144015
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 1
- Public Version Date
- 2023-05-24
- Public Version Status
- New
- Public Device Record Key
- cda7ff9a-43a5-4f2c-9940-0809697aafe6
Device Description
SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 05030267159796 | GS1 | 40 | In Commercial Distribution | ||
| Primary | 05030267159789 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122075 | 000 |