Spirometrics

Basic Information

• Brand Name: Spirometrics
• Primary DI: 00855784004207
• Version / Model: N4010
• Catalog Number: N4010-2
• Company Name: Spirometrics
• Labeler DUNS: 830864406
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-03
• Public Version: 3
• Public Version Date: 2020-09-24
• Public Version Status: Update
• Public Device Record Key: 6837a2ad-3c54-401d-8769-4d7358a04863
• Distribution End Date: 2020-08-28

Device Description

3 Liter Calibration Syringe, Spirometrics label

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
60343	Gas volume reference standard	A manual instrument intended to deliver a precise, known quantity of gas (e.g., 1 litre) for the purposes of calibrating/testing a medical device partially or completely dedicated to measuring/monitoring volumes of air/gas (e.g., anaesthesia monitor, diagnostic spirometer). It is typically presented as a syringe-like device with a manually-operated plunger and may include appropriate connecting tubing. This device is intended to be used by a healthcare provider in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855784004207	GS1

Customer Contacts

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