AccessGUDID - DEVICE: Plastic Cath'N Sleeve (00801741050190)

GUDID

Device Identifier (DI) Information

Brand Name: Plastic Cath'N Sleeve
Version or Model: 0089080
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0089080
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741050190
Issuing Agency: GS1
Commercial Distribution End Date: May 13, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Plastic Cath'N Sleeve With Solution Container

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?
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	Active	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: 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
Length: 16 Inch
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: 52e299ac-c7a3-44a1-aa7f-cb8560df6896
Public Version Date: May 18, 2022
Public Version Number: 2
DI Record Publish Date: September 21, 2020