AccessGUDID - DEVICE: Suction Catheter Kit (00848530082062)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Catheter Kit
Version or Model: TRATK108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRATK108
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530082062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most.

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?
40249	Tracheostomy suction kit	A collection of sterile devices and supplies intended to suction secretions from the trachea and bronchi through a tracheostomy tube. It typically includes a tracheal suctioning catheter with an appropriate tip (e.g., a whistle tip for adults, a smaller one for children) and a thumb operated valve, a pair of gloves, and a container for the aspirates. It is typically intended to be used with a suction machine. Some types include an inner cannula replacement for the tracheostomy tube. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OFS	Tracheal Suction Set

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 598c5fca-be6b-4d55-8eed-df097095044d
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018