FDA UDI
In Commercial Distribution
🇺🇸 United States
StatCO2 End Tidal CO2 Detector
DI: 10641043553701
·
Model: 10-55370
·
MERCURY ENTERPRISES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- StatCO2 End Tidal CO2 Detector
- Primary DI
- 10641043553701
- Version / Model
- 10-55370
- Company Name
- MERCURY ENTERPRISES, INC.
- Labeler DUNS
- 032705659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-08
- Public Version
- 5
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- f1eb5e31-6220-45ca-aab8-202158762441
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
- 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 | A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing exhaled carbon dioxide (CO2) during airway management to confirm correct intubation for appropriate ventilation; it may additionally be intended to confirm placement/ventilation when using a laryngeal mask airway and/or face mask. It is intended to be connected to the intubation device and/or ventilator breathing circuit (e.g., the T-piece connector or hose). It typically functions through colorimetric CO2 detection using a chemical reaction based and/or paper indicator that changes colour based on the approximate CO2 concentration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10641043553701 | GS1 | ||||
| Package | 30641043553705 | GS1 | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- (727) 573-0088
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021576 | 000 |