AccessGUDID - DEVICE: ERBEFLO CleverCap® (04065655000603)

GUDID

Device Identifier (DI) Information

Brand Name: ERBEFLO CleverCap®
Version or Model: 20325-201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20325-201
Company Name: Erbe Medical, LLC

Primary DI Number: 04065655000603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117862528 *Terms of Use
Previous DI: 04050147012776

Device Description: Hybrid Tubing/Cap Set for Olympus® Scopes

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?
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221177	000

Device Exempt from Premarket Submission: No 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 away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 3.5 Meter

Device Record Status

Public Device Record Key: afb1d3a3-a9fd-47b5-9678-71998aec179f
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 22, 2023