AccessGUDID - DEVICE: CollectEVAC (00841436104579)

GUDID

Device Identifier (DI) Information

Brand Name: CollectEVAC
Version or Model: 610-954
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 610-954
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436104579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Sterile device with tubing and adapter for use with ACMI and STORZ/Wolf resectoscopes

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
14301	Urological irrigation set	A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQT	EVACUATOR, GASTRO-UROLOGY

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Height: 17.8 Centimeter
Length: 18.3 Centimeter

Device Record Status

Public Device Record Key: e31936da-9e24-4b7c-9973-794178f95774
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: January 03, 2018