AccessGUDID - DEVICE: Resp-O2 Suction Catheter Kit, 14 FR, Sterile (00840117309159)

GUDID

Device Identifier (DI) Information

Brand Name: Resp-O2 Suction Catheter Kit, 14 FR, Sterile
Version or Model: 32054
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117309159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: Sterile-EO, Contents: 1 - Adult Graduated Catheter with Control Valve, 1 Pair of Powder-Free Vinyl Exam Gloves, 1 Pop-Up Basin.

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:	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?
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BSY	Catheters, Suction, Tracheobronchial

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: 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: d4a1cea5-053e-4060-a4ff-aaf7ac30708f
Public Version Date: November 11, 2024
Public Version Number: 4
DI Record Publish Date: May 10, 2022