Identity
- Trade Name
- 3L Calibration Syringe FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- The 3L calibration syringe is a hollow cylindrical tube with a nozzle at one end that connects to a VectraCor pneumotachometer, and a handle/plunger on the other end. As the handle is pulled back the tube fills with a known quantity of air. If the device is connected to a VectraCor spirometer device with a VectraCor pneumotachometer, as the handle is depressed air is pushed into the spirometer. This will allow users to check if the VectraCor spirometer device is within calibration values. FDA UDI
- Model / Reference
- 5000-1917 FDA UDI
- Description
- The 3L calibration syringe is a hollow cylindrical tube with a nozzle at one end that connects to a VectraCor pneumotachometer, and a handle/plunger on the other end. As the handle is pulled back the tube fills with a known quantity of air. If the device is connected to a VectraCor spirometer device with a VectraCor pneumotachometer, as the handle is depressed air is pushed into the spirometer. This will allow users to check if the VectraCor spirometer device is within calibration values. FDA UDI
Identifiers
- Catalog Number
- 5000-1917 FDA UDI
- Primary DI / UDI-DI
- 00857175006067 FDA UDI
- FDA Product Code
- BXW FDA UDI
- GMDN Term
- Spirometer/pulmonary function analyser syringe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.1870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spirometer/pulmonary function analyser syringe
3L Calibration Syringe by Vectracor, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vectracor, Inc.
Sources (1)
- FDA UDI fb4ebeee-536c-4543-87fa-73f096978060 34 fields · synced May 30, 2026