Coda®

Basic Information

• Brand Name: Coda®
• Primary DI: 00815965021171
• Version / Model: A800-008
• Catalog Number: A800-008
• Company Name: LIFEGLOBAL GROUP, LLC
• Labeler DUNS: 141732011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 62673c78-ea36-4652-99e0-c321d62cd807

Device Description

CodaAir 800, 24V universal adapter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MQG	ACCESSORY, ASSISTED REPRODUCTION	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11711	Non-respiratory device ambient air filter	A filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation/management. It is composed of tightly woven materials which remove particulates/impurities and, depending on how the device is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, liquidize air as in a flotation therapy bed, wash/disinfect surgical instruments), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After installation, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815965021171	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001486	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .5 – 1.06 KiloPascal