Spirometrics

Basic Information

• Brand Name: Spirometrics
• Primary DI: 00855784004290
• Version / Model: D1060
• 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: 4
• Public Version Date: 2020-09-24
• Public Version Status: Update
• Public Device Record Key: 0c3d9a71-88d9-48b6-bcf3-0517d7aafc98
• Distribution End Date: 2020-08-28

Device Description

Nose Clip, each

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
BXJ	Clip, Nose	Anesthesiology	868.6225	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10907	Nose clip, single-use	A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855784004191	GS1	box	3	Not in Commercial Distribution	2020-08-28
Package	00855784004184	GS1	box	200	Not in Commercial Distribution	2020-08-28
Primary	00855784004290	GS1
Package	00855784004177	GS1	dispenser box	200	Not in Commercial Distribution	2020-08-28

Customer Contacts

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