AccessGUDID - DEVICE: HUDSON RCI (14026704617408)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN048996
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-16037
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704617408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704397617

Device Description: ET TUBE, SHER-I-BRONCH, LS, 37 FR

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":	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?
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 [?]
K180253	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
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: None

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sher-I-Bronch Endobronchial Tube

Device Record Status

Public Device Record Key: a2e311ba-0034-4618-87cb-66ed4fee871c
Public Version Date: February 07, 2025
Public Version Number: 18
DI Record Publish Date: September 20, 2018