ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147012950
• Version / Model: 20325-231
• Catalog Number: 20325-231
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 6
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: 0b7cce3e-440f-4616-b4f5-f90929eee725
• Distribution End Date: 2023-09-20

Device Description

Air and Water Tubing/Cap Set for Olympus® Scopes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEQ	PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04050147013506	GS1	Level: 2	5	Not in Commercial Distribution	2023-09-20
Package	04050147013490	GS1	Level: 1	10	Not in Commercial Distribution	2023-09-20
Primary	04050147012950	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132340	000

Device Sizes

Type	Value	Unit	Text
Length	0.400	Meter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat and direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry