FDA UDI
In Commercial Distribution
🇺🇸 United States
3L Calibration Syringe
DI: 00857175006067
·
Model: 5000-1917
·
VECTRACOR INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3L Calibration Syringe
- Primary DI
- 00857175006067
- Version / Model
- 5000-1917
- Catalog Number
- 5000-1917
- Company Name
- VECTRACOR INC
- Labeler DUNS
- 828416359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-07
- Public Version
- 1
- Public Version Date
- 2023-06-15
- Public Version Status
- New
- Public Device Record Key
- fb4ebeee-536c-4543-87fa-73f096978060
Device 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.
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BXW | Calibrator, Volume, Gas | Anesthesiology | 868.1870 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17250 | Spirometer/pulmonary function analyser syringe | A dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or plastic cylinder (barrel) and steel plunger (piston) with a finely graduated scale along the length of the cylinder. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857175006067 | GS1 |