SpiraLith Ca

Basic Information

• Brand Name: SpiraLith Ca
• Primary DI: 00860008449832
• Version / Model: Rx-3719C
• Company Name: Micropore, Inc.
• Labeler DUNS: 042903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: 45abc35b-79f4-4b41-aa30-9f54f4b16d39

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
42414	Carbon dioxide absorber, single-use	A non-sterile, prefilled, sealed container (i.e., a canister with connectors) that constitutes a complete anaesthesia absorber, which is intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled by the manufacturer with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime) to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860008449839	GS1	Box	6	In Commercial Distribution
Primary	00860008449832	GS1