FDA UDI
In Commercial Distribution
🇺🇸 United States
PreciseRx™ Pediatric Flowmeter
DI: 00850018761291
·
Model: IRCPF16
·
VENTEC LIFE SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PreciseRx™ Pediatric Flowmeter
- Primary DI
- 00850018761291
- Version / Model
- IRCPF16
- Catalog Number
- IRCPF16
- Company Name
- VENTEC LIFE SYSTEMS, INC.
- Labeler DUNS
- 078758082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- fd5f2896-0731-4e60-aedf-61519bc44371
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
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 | 00850018761291 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914488 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 158 Degrees Fahrenheit