FDA UDI
In Commercial Distribution
🇺🇸 United States
GENTEC®
DI: 06970966662809
·
Model: CFM-15L
·
GENTEC(SHANGHAI)CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GENTEC®
- Primary DI
- 06970966662809
- Version / Model
- CFM-15L
- Company Name
- GENTEC(SHANGHAI)CORPORATION
- Labeler DUNS
- 545287658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-09
- Public Version
- 1
- Public Version Date
- 2021-11-17
- Public Version Status
- New
- Public Device Record Key
- 98fc2e6d-2267-4679-a52c-406cbd99f99b
- Distribution End Date
- 2031-11-09
Device Description
CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient's inhalation, and other medical devices' flow control and monitor as well.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61366 | Medical gas flowmeter, dial-type | A device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970966662809 | GS1 |