AccessGUDID - DEVICE: 3L Calibration Syringe (00857175006067)

GUDID

Device Identifier (DI) Information

Brand Name: 3L Calibration Syringe
Version or Model: 5000-1917
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5000-1917
Company Name: VECTRACOR INC

Primary DI Number: 00857175006067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828416359 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXW	Calibrator, Volume, Gas

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb4ebeee-536c-4543-87fa-73f096978060
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023