AccessGUDID - DEVICE: ProCure (10840330703458)

GUDID

Device Identifier (DI) Information

Brand Name: ProCure
Version or Model: 1005589
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1005589
Company Name: Twin Med, LLC

Primary DI Number: 10840330703458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107071289 *Terms of Use

Device Description: Closed Suction Catheter, 14Fr, T-Piece, Tracheostomyl, 72 Hour, with 22mm flex adapter, with Swivel, with HME Adapter, with Trach Wedge, with MDI Adapter

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
Catheter Gauge: 14 French
Catheter Inner Diameter: 4.6 Millimeter
Length: 30.5 Centimeter

Device Record Status

Public Device Record Key: 8673f07a-5bde-40c1-a9bf-aca5a4d5cb42
Public Version Date: April 17, 2024
Public Version Number: 1
DI Record Publish Date: April 09, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30840330703452	10	10840330703458	In Commercial Distribution	Box
50840330703456	2	30840330703452	In Commercial Distribution	Case
70840330703450	5	50840330703456	In Commercial Distribution	Carton