AccessGUDID - DEVICE: ERBEFLO CleverCap® (04065655001099)

GUDID

Device Identifier (DI) Information

Brand Name: ERBEFLO CleverCap®
Version or Model: 20325-208
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20325-208
Company Name: Erbe Medical, LLC

Primary DI Number: 04065655001099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117862528 *Terms of Use
Previous DI: 04050147012837

Device Description: Hybrid CO2 Tubing/Cap Set for Fujinon® 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?
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEQ	Pump, Air, Non-Manual, For Endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162152	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: 2001571b-fa13-4be2-bfd7-69dd85e60d9f
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 22, 2023