AccessGUDID - DEVICE: FLOCAP, MEDLINE 24 PK (20817770020817)

GUDID

Device Identifier (DI) Information

Brand Name: FLOCAP, MEDLINE 24 PK
Version or Model: R500P21-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MAXTEC, LLC

Primary DI Number: 20817770020817
Issuing Agency: GS1
Commercial Distribution End Date: February 06, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 169911828 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
17614	Exhaled-gas oesophageal intubation detector	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing exhaled carbon dioxide (CO2) during airway management to confirm correct intubation for appropriate ventilation; it may additionally be intended to confirm placement/ventilation when using a laryngeal mask airway and/or face mask. It is intended to be connected to the intubation device and/or ventilator breathing circuit (e.g., the T-piece connector or hose). It typically functions through colorimetric CO2 detection using a chemical reaction based and/or paper indicator that changes colour based on the approximate CO2 concentration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 120fdfda-e5f0-4501-8197-5dee5efe3670
Public Version Date: August 15, 2024
Public Version Number: 6
DI Record Publish Date: September 27, 2016