AccessGUDID - DEVICE: SILBRONCHO (RIGHT LUNG) (04544050123990)

GUDID

Device Identifier (DI) Information

Brand Name: SILBRONCHO (RIGHT LUNG)
Version or Model: #37
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1203637
Company Name: FUJI SYSTEMS CORPORATION

Primary DI Number: 04544050123990
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 715919973 *Terms of Use
Previous DI: 04544050083942

Device Description: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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?
31328	Endobronchial tube	A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051522	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 43e0f2bc-f5f3-47cd-945c-6800cb1012dd
Public Version Date: September 13, 2023
Public Version Number: 1
DI Record Publish Date: September 05, 2023