AincA®

Basic Information

• Brand Name: AincA®
• Primary DI: B005E18815540
• Version / Model: E-188-15-54
• Catalog Number: E-188-15-54
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Labeler DUNS: 002065670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: 13444879-f20e-4ccf-9cd3-07cb11067e57

Device Description

Bag, Breathing, FLAT, 54mm Female Rubber Bushing, 15 liter, Gray Latex

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• 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
BTC	BAG, RESERVOIR	Anesthesiology	868.5320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37709	Breathing circuit bag, reusable	A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B005E18815540	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	15	Liter