ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147013032
• Version / Model: 20325-322
• Catalog Number: 20325-322
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 5
• Public Version Date: 2019-04-23
• Public Version Status: Update
• Public Device Record Key: 3714dd7b-e45f-4e18-a61c-530f00b006eb

Device Description

Endoscopy Pump Tubing /Cap Set

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
OCX	endoscopic irrigation/suction system	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04050147013667	GS1	Level: 2	5	In Commercial Distribution
Package	04050147013650	GS1	Level: 1	10	In Commercial Distribution
Primary	04050147013032	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103235	000

Device Sizes

Type	Value	Unit	Text
Length	2.900	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