PreciseRx™ Pediatric Flowmeter IRCPF16
GUDID 00850018761291
VENTEC LIFE SYSTEMS, INC.
Medical gas flowmeter, Thorpe tube| Primary Device ID | 00850018761291 |
| NIH Device Record Key | fd5f2896-0731-4e60-aedf-61519bc44371 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PreciseRx™ Pediatric Flowmeter |
| Version Model Number | IRCPF16 |
| Catalog Number | IRCPF16 |
| Company DUNS | 078758082 |
| Company Name | VENTEC LIFE SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018761291 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K914488
FDA Product Code
| CAW | Generator, Oxygen, Portable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
Devices Manufactured by VENTEC LIFE SYSTEMS, INC.
| 00850018761321 - Platinum® 10L Oxygen Concentrator | 2024-12-30 |
| 00850018761383 - VOCSN Passive Valve | 2024-12-10 |
| 00850018761307 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761352 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761369 - HomeFill® Oxygen System | 2023-10-24 |
| 00850018761376 - HomeFill® Oxygen System | 2023-10-24 |
| 00855573007822 - VOCSN | 2023-07-10 |
| 00850018761291 - PreciseRx™ Pediatric Flowmeter | 2023-06-26 |
| 00850018761291 - PreciseRx™ Pediatric Flowmeter | 2023-06-26 |
Trademark Results [PreciseRx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRECISERX 88517928 not registered Live/Pending |
Healthware Inc. 2019-07-16 |
 PRECISERX 76532936 not registered Dead/Abandoned |
Dubin Medical Inc. 2003-07-28 |
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