FDA UDI
In Commercial Distribution
🇺🇸 United States
Ventlab
DI: 30889483275546
·
Model: 5714F-SE-E
·
VENTLAB, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ventlab
- Primary DI
- 30889483275546
- Version / Model
- 5714F-SE-E
- Catalog Number
- 5714F-SE-E
- Company Name
- VENTLAB, LLC
- Labeler DUNS
- 038305402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- 974e3919-0910-41ed-bd6e-a4fa0e56c25b
Device Description
Adult EXTENDED ETCO2/O2 OralNasalCannula w/ 14' Soft-Ears Tubing,ReflectiveConnector,Filter,Fits-All
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 17614 | Exhaled-gas oesophageal intubation detector, adult | A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during adult intubation and is attached directly between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30889483275546 | GS1 |
Customer Contacts
- Phone
- +1(800)433-2797
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Feet |