Spirometrics

Basic Information

• Brand Name: Spirometrics
• Primary DI: 00855784004283
• Version / Model: D1020
• 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: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0a49aab2-03cb-4a79-8c2c-86c7739f641d
• Distribution End Date: 2020-08-28

Device Description

Adult Mouthpiece, 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
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00855784004146	GS1	box	10	Not in Commercial Distribution	2020-08-28
Package	00855784004122	GS1	box	100	Not in Commercial Distribution	2020-08-28
Primary	00855784004283	GS1
Package	00855784004139	GS1	box	4	Not in Commercial Distribution	2020-08-28
Package	00855784004115	GS1	box	5	Not in Commercial Distribution	2020-08-28
Package	00855784004092	GS1	bag	200	Not in Commercial Distribution	2020-08-28
Package	00855784004108	GS1	box	2	Not in Commercial Distribution	2020-08-28

Customer Contacts

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