FDA UDI
In Commercial Distribution
🇺🇸 United States
MFT 25 _ AIR DS _ 9/16 G
DI: 08592346749375
·
Model: 0726502US
·
GCE, s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MFT 25 _ AIR DS _ 9/16 G
- Primary DI
- 08592346749375
- Version / Model
- 0726502US
- Company Name
- GCE, s.r.o.
- Labeler DUNS
- 819753190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-17
- Public Version
- 1
- Public Version Date
- 2021-02-25
- Public Version Status
- New
- Public Device Record Key
- d18c3dd5-0a9a-4dee-a1c3-dd0f2b6a771f
Device Description
Mediflow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | Anesthesiology | 868.2340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61365 | Medical gas flowmeter, Thorpe tube | A device intended to measure and 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 consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. 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 | 08592346749375 | GS1 |