AccessGUDID - DEVICE: RediTube™ (10885403296086)

GUDID

Device Identifier (DI) Information

Brand Name: RediTube™
Version or Model: 8080RTC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8080RTC
Company Name: Carefusion Corporation

Primary DI Number: 10885403296086
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830432451 *Terms of Use

Device Description: RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet

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:	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?
46967	Basic endotracheal tube, single-use	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042683	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: less than 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8.0 Millimeter
Outer Diameter: 10.9 Millimeter
Device Size Text, specify: Cuff Resting Diameter: 26±15% Millimeters

Device Record Status

Public Device Record Key: 7d490cd0-8922-478b-90f6-31fafcea0888
Public Version Date: May 30, 2024
Public Version Number: 5
DI Record Publish Date: August 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885403296084	4	20885403296083	2022-03-31	Not in Commercial Distribution	CS
70885403296088	20	10885403296086	2022-03-31	Not in Commercial Distribution	PAK
20885403296083	2	70885403296088	2022-03-31	Not in Commercial Distribution	BOX