Precision Syringe

Basic Information

• Brand Name: Precision Syringe
• Primary DI: 15099169360225
• Version / Model: 2040
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• Labeler DUNS: 219683489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4e24b37c-31d0-4909-a65b-7b3efc559900

Device Description

2040 PRECISION SYRINGE 3 LITRE

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: 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
Package	05099169360228	GS1		1	In Commercial Distribution
Primary	15099169360225	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius