FDA UDI
In Commercial Distribution
🇺🇸 United States
SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE
DI: 05030267157686
·
Model: 1143017
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE
- Primary DI
- 05030267157686
- Version / Model
- 1143017
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-27
- Public Version
- 3
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- f73f05b7-41a3-4e48-b190-420285d7593e
Device Description
SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH 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 |
|---|---|---|---|---|
| 35171 | Rebreathing oxygen face mask | A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267159413 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 05030267157686 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]