AccessGUDID - DEVICE: ProCure (10840330704844)

GUDID

Device Identifier (DI) Information

Brand Name: ProCure
Version or Model: 1006230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1006230
Company Name: Twin Med, LLC

Primary DI Number: 10840330704844
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107071289 *Terms of Use

Device Description: ProCure Suction Catheter, 6 Fr, 12" Length, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge

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):	No
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: 6 French
Outer Diameter: 0.2 Centimeter
Length: 12 Inch

Device Record Status

Public Device Record Key: e8806b7c-f7c7-445c-8869-61560ba85cfe
Public Version Date: May 22, 2024
Public Version Number: 1
DI Record Publish Date: May 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30840330704848	10	10840330704844	In Commercial Distribution	Box
50840330704842	2	30840330704848	In Commercial Distribution	Case
70840330704846	5	50840330704842	In Commercial Distribution	Carton