AincA®

Basic Information

• Brand Name: AincA®
• Primary DI: B00500281P0506
• Version / Model: 00-281-P-050
• Catalog Number: 00-281-P-050
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Labeler DUNS: 002065670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: e06c8570-1aec-4758-95b7-b58e7e3e8bc7

Device Description

Mouthpiece, Disposable, Pediatric, fits (00-174) Low Range Mini-Wright, Pack of 50

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• 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
BZG	SPIROMETER, DIAGNOSTIC	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31266	Incentive spirometer	A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B00500281P0500	HIBCC
Primary	B00500281P0506	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pediatric