FDA UDI
In Commercial Distribution
🇺🇸 United States
Flow Analyzer PF-300 PRO
DI: 07640214642707
·
Model: 700.300.000
·
IMT Analytics AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Flow Analyzer PF-300 PRO
- Primary DI
- 07640214642707
- Version / Model
- 700.300.000
- Company Name
- IMT Analytics AG
- Labeler DUNS
- 480035934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 1
- Public Version Date
- 2022-11-25
- Public Version Status
- New
- Public Device Record Key
- 62acfdd8-7958-49f8-aed7-168f885b4200
Device Description
Flowmeter, calibration, gas
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| BXY | Flowmeter, Calibration, Gas | Anesthesiology | 868.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31283 | Anaesthesia/respiratory gas flowmeter tester | A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07640214642714 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07640214642707 | GS1 |