FDA UDI
In Commercial Distribution
🇺🇸 United States
FENEM
DI: 00841470108359
·
Model: 301-5585
·
ENGINEERED MEDICAL SYSTEMS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- FENEM
- Primary DI
- 00841470108359
- Version / Model
- 301-5585
- Company Name
- ENGINEERED MEDICAL SYSTEMS INC
- Labeler DUNS
- 154502934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-12
- Public Version
- 2
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- b4801a8f-f9cb-41c6-b48d-47cfe453dac9
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
- No
- 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 |
|---|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 868.5915 | 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 |
|---|---|---|---|---|---|---|
| Package | 10841470108356 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00841470108359 | GS1 | ||||
| Package | 20841470108353 | GS1 | 120 | In Commercial Distribution |