AccessGUDID - DEVICE: Pilot Tube Repair Kit (M996BE4090)

GUDID

Device Identifier (DI) Information

Brand Name: Pilot Tube Repair Kit
Version or Model: BE 409
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BE 409
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BE4090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient.

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?
37555	Tracheal pilot tube repair kit	A collection of devices designed to restore the integrity of a damaged endotracheal (ET)/tracheostomy pilot tube when it is no longer maintaining the tracheal cuff pressure. Such a repair can deter the need to replace the entire endotracheal/tracheostomy tube because of a damaged pilot tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSK	Cuff, Tracheal Tube, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 655a4a83-e7cc-452c-9015-7de492edfd78
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 31, 2015