DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V

Basic Information

• Brand Name: DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V
• Primary DI: 05030267063710
• Version / Model: 2186000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-28
• Public Version: 2
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: 82164312-a128-432a-b883-5f8d669941b9

Device Description

DRUM: 1KG SODA LIME CARTRIDGE SPHERASORB - W/V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
36051	Carbon dioxide absorbent	An absorbent material (e.g., granules of treated soda lime) intended to be placed into a reusable carbon dioxide absorber to remove carbon dioxide (CO2) from the exhaled gases in a patient breathing circuit by chemical reaction. It is typically available in large plastic containers [e.g., 5 kilogrammes (Kg) by weight] and poured into clean, reusable absorbers. The absorbent is typically manufactured to change colour during its use (e.g., from white to violet, pink to white, or green to violet) to indicate need for replacement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05030267047086	GS1		10	In Commercial Distribution
Primary	05030267063710	GS1

Customer Contacts

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