AccessGUDID - DEVICE: Catheter Mount Tubing; with right angled swivel connector with bronchoscope/suct (14250105628897)

GUDID

Device Identifier (DI) Information

Brand Name: Catheter Mount Tubing; with right angled swivel connector with bronchoscope/suct
Version or Model: 65-88-130
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 14250105628897
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use
Previous DI: 04250105602432

Device Description: n.a.

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":	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?
46819	Breathing circuit catheter mount, reusable	A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: keep dry, keep away from sunlight and heat

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length: 18 cm / Tubing: 13 cm ; 15 mm I.D., 22 mm O.D. / 22 mm I.D. ; bronchoscope / suction cap (5.0 mm)

Device Record Status

Public Device Record Key: ea893c90-2078-4581-bcd2-2b3d474f5a5e
Public Version Date: December 02, 2021
Public Version Number: 2
DI Record Publish Date: September 18, 2020