AccessGUDID - DEVICE: Coda® (00815965021850)

GUDID

Device Identifier (DI) Information

Brand Name: Coda®
Version or Model: CPPA-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CPPA-001
Company Name: LIFEGLOBAL GROUP, LLC

Primary DI Number: 00815965021850
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 141732011 *Terms of Use

Device Description: Coda Eco 1200/1500/+Press. Initial/Annual kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQG	ACCESSORY, ASSISTED REPRODUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001486	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90226323-45f9-485f-aa6a-2c7f6d54e6f7
Public Version Date: October 03, 2024
Public Version Number: 5
DI Record Publish Date: September 28, 2016