FDA.reportPublic FDA data

3L Calibration Syringe

Primary DI
00857175006067
Brand
3L Calibration Syringe
Company
VECTRACOR INC
Model
5000-1917
Catalog number
5000-1917
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.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXWCalibrator, Volume, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXWCalibrator, Volume, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857175006067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857175006067008571750060678571750060670857175006067

GMDN Terms#

Term, Definition table
TermDefinition
Spirometer/pulmonary function analyser syringeA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828416359
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857175006029VectraplexECG System3.4.22016-09-26
00857175006166Office Medic6.02017-01-23
10857175006071Plastic Mouthpieces (100)Z-5000-26082016-09-26
00857175006173Universal SmartECGAHAZ-7000-05002023-06-07
00857175006043Universal ECGZ-7000-0301Z-7000-03012016-09-24
00857175006012Vectraplex CMSV1007052016-09-26
00857175006050Orbit SpirometerZ-7000-0101Z-7000-01012016-09-24
10857175006132Wet Gel Monitoring ElectrodesV1003002016-09-26
40857175006096Adhesive Solid Gel Electrodes (pack of 100)Z-5000-19202016-09-26
10857175006088Nose Clips724050-002016-09-26
20857175006085Nose Clips7242005-002017-02-03
00857175006111Holter Prep Kit701900-002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008171360277395530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
008171360277465530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
34250892907407JaegerJaeger Medical GmbHBXW2025-07-24
34250892907421JaegerJaeger Medical GmbHBXW2025-07-24
04250892907413JaegerJaeger Medical GmbHBXW2025-07-23
04250892907888JaegerJaeger Medical GmbHBXW2025-07-23
008170810279143 Liter Aluminum Calibration Syringe w/ AdapterA-M SYSTEMS, LLCBXW2024-11-07
008171360276855530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-07-02
008171360276785530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-02-13
008171360276615570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-11-08
008171360276545570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-21
008171360276475570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-17
00817081027594Syringe, Calibration, Adj. Vol., AluminumA-M SYSTEMS, LLCBXW2023-05-17
008171360270435540 1L SYRINGEHANS RUDOLPH, INC.BXW2023-01-05
008171360270365570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-12-16
008171360269095530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360269165530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360268795530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-05-16
008171360268005570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-03-08
04250892906645VyaireJaeger Medical GmbHBXW2021-11-15
008170810271053 Liter Aluminum Calibration SyringeA-M SYSTEMS, LLCBXW2021-10-06
008171360267495530 3L SYRINGEHANS RUDOLPH, INC.BXW2021-09-23
00817081027051SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,A-M SYSTEMS, LLCBXW2021-09-09
008171360267185570 3L SYRINGEHANS RUDOLPH, INC.BXW2021-08-06
04250892906102VyaireJaeger Medical GmbHBXW2021-07-16
04250892906140VyaireJaeger Medical GmbHBXW2021-07-16
34250892906110VyaireJaeger Medical GmbHBXW2021-07-16
34250892906127VyaireJaeger Medical GmbHBXW2021-07-16
34250892906134VyaireJaeger Medical GmbHBXW2021-07-16
34250892906158VyaireJaeger Medical GmbHBXW2021-07-16