SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE

Basic Information

• Brand Name: SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE
• Primary DI: 05030267162338
• Version / Model: 2169001
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-01
• Public Version: 1
• Public Version Date: 2022-02-09
• Public Version Status: New
• Public Device Record Key: 8e8036cf-f0af-46f6-8d61-1581b8952743

Device Description

SMARTCAN™ SPHERASORB™ DISPOSABLE CO2 ABSORBER, WHITE TO VIOLET COLOUR CHANGE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: 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
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	05030267162345	GS1		6	In Commercial Distribution
Primary	05030267162338	GS1

Customer Contacts

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