AccessGUDID - DEVICE: Medichoice (10885632127137)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: TRAC1002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632127137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Kit Tracheostomy Care Hydrogen Peroxide Pipe Cleaner Twill Tape Trach Brush 6In Cta 4X4In Gauze Split Trach Dressing Drape Glove Latex-Free Sterile MediChoice

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":	Yes
For Single-Use:	Yes
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?
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGW	Tracheostomy kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify:
Special Storage Condition, Specify: avoid freezing and excessive heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c03ac7fe-9a70-4c2c-a38d-5d8e74e876ed
Public Version Date: October 21, 2020
Public Version Number: 3
DI Record Publish Date: August 20, 2016