AccessGUDID - DEVICE: SPIRAFLEX (04051948025316)

GUDID

Device Identifier (DI) Information

Brand Name: SPIRAFLEX
Version or Model: 17503-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Andreas Fahl Medizintechnik-Vertrieb GmbH

Primary DI Number: 04051948025316
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 314768383 *Terms of Use

Device Description: SPIRAFLEX UNI CUFF, SIZE 11

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:	No
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?
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)
BTO	Tube, Tracheostomy (W/Wo Connector)
JOH	Tube Tracheostomy And Tube Cuff

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: 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: 3a9d4c75-896a-4f35-8607-d2846d7bae0b
Public Version Date: October 13, 2021
Public Version Number: 4
DI Record Publish Date: December 29, 2016