AccessGUDID - DEVICE: Expandable 15 mm x 5 inch Flex Tube (00636207315458)

GUDID

Device Identifier (DI) Information

Brand Name: Expandable 15 mm x 5 inch Flex Tube
Version or Model: VMFLEX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VMFLEX
Company Name: Global Life Sciences Solutions USA LLC

Primary DI Number: 00636207315458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011658242 *Terms of Use

Device Description: Expandable 15 mm x 5 inch Flex tube, Non-sterile, Single Patient Use

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?
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
CAH	Filter, bacterial, breathing-circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013093	000

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
Length: 5 Inch

Device Record Status

Public Device Record Key: 651e47cf-ad9d-40cc-8bfb-061c6066bbb3
Public Version Date: February 29, 2024
Public Version Number: 6
DI Record Publish Date: June 29, 2016