SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,

Basic Information

• Brand Name: SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,
• Primary DI: 00817081027051
• Version / Model: 192803 - CHS
• Catalog Number: 192803
• Company Name: A-M SYSTEMS, LLC
• Labeler DUNS: 020275145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-09
• Public Version: 1
• Public Version Date: 2021-09-17
• Public Version Status: New
• Public Device Record Key: 5f2e465f-fca9-4f33-abc5-5bb31eef758d

Device Description

SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,WITH MODIFIED FRONT CAP & 1138 ADAPTER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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	00817081027051	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]