A200SP Absorber MRI

Basic Information

• Brand Name: A200SP Absorber MRI
• Primary DI: 05051977000109
• Version / Model: A200SP
• Company Name: PENLON LTD
• Labeler DUNS: 458942687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-27
• Public Version: 3
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 3e211df9-d9da-4d5f-83fc-ebc830fec492

Device Description

Anaesthesia Absorber for use in MRI environment and all clinical environments.

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
BSF	Absorber, Carbon-Dioxide	Anesthesiology	868.5310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37021	Anaesthesia breathing circuit, reusable	An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051977000109	GS1