DEVICE: ProCure (10840330703458)
Device Identifier (DI) Information
ProCure
1005589
In Commercial Distribution
1005589
Twin Med, LLC
1005589
In Commercial Distribution
1005589
Twin Med, LLC
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
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 14 French |
Catheter Inner Diameter: 4.6 Millimeter |
Length: 30.5 Centimeter |
Device Record Status
8673f07a-5bde-40c1-a9bf-aca5a4d5cb42
April 17, 2024
1
April 09, 2024
April 17, 2024
1
April 09, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | 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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
612-819-1635
sanderson@twinmed.com
sanderson@twinmed.com