AccessGUDID - DEVICE: Catheter Mount Tubing with right angled double swivel connector (04250105629866)

GUDID

Device Identifier (DI) Information

Brand Name: Catheter Mount Tubing with right angled double swivel connector
Version or Model: 60-85-150-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 04250105629866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use
Previous DI: 04250105604856

Device Description: Length: 19 cm / Tubing: 15 cm ; 15 mm I.D., 22 mm O.D. / 15 mm O.D. ; bronchoscope / suction cap (5.0 mm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
42476	Breathing circuit catheter mount, single-use	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; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use 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: Yes
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
Catheter Length: 15 Centimeter
Lumen/Inner Diameter: 15 Millimeter
Outer Diameter: 22 Millimeter

Device Record Status

Public Device Record Key: 7382f43c-0435-449a-a490-4c2363a3b6c1
Public Version Date: November 02, 2023
Public Version Number: 1
DI Record Publish Date: October 25, 2023