AccessGUDID - DEVICE: Suction Tubing (00848530095956)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Tubing
Version or Model: VEN46001200M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530095956
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Standard CSS, Adult, 24-hours, Endotrac, 540mm, MDI Port, 12Fr, Standard Switch, s

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:	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?
63465	Closed-suction breathing circuit connector/switch	A sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a770ef8c-551b-4673-9251-5a002c16c21a
Public Version Date: August 12, 2024
Public Version Number: 1
DI Record Publish Date: August 02, 2024