AMSORB® PLUS

Basic Information

• Brand Name: AMSORB® PLUS
• Primary DI: 15059443014466
• Version / Model: AMAB4001GE
• Company Name: ARMSTRONG MEDICAL LTD
• Labeler DUNS: 239659915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-18
• Public Version: 1
• Public Version Date: 2021-08-26
• Public Version Status: New
• Public Device Record Key: 98c0758f-b9e2-4e02-bd8a-f55305732ade

Device Description

AMAB40001GE - 2105489-011 AMSORB PLUS BUBBLE-CAN UNIVERSAL 1.2L.

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	868.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46233	Carbon dioxide absorbent cartridge	A non-sterile, prefilled, sealed container (cartridge or drum) containing a carbon dioxide absorbent material (e.g., granules of treated soda lime) intended to be inserted into a reusable anaesthesia system absorber for the removal of carbon dioxide (CO2) exhaled by a patient into an anaesthesia unit/workstation breathing circuit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15059443014466	GS1