Disposable PFT Nose Clip with Foam Pads

Basic Information

• Brand Name: Disposable PFT Nose Clip with Foam Pads
• Primary DI: 00817081027495
• Version / Model: Foam Pad nose clip - 166527
• Catalog Number: 166527
• Company Name: A-M SYSTEMS, LLC
• Labeler DUNS: 020275145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-16
• Public Version: 1
• Public Version Date: 2023-03-24
• Public Version Status: New
• Public Device Record Key: 320f07cd-c85c-4b5f-b384-7cd45f54071a

Device Description

Disposable Pulmonary Function Testing Nose Clip with Foam Pads

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: 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
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	00817081027501	GS1		25	In Commercial Distribution
Primary	00817081027495	GS1

Customer Contacts

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