AccessGUDID - DEVICE: ERBE (04050147012806)

GUDID

Device Identifier (DI) Information

Brand Name: ERBE
Version or Model: 20325-205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20325-205
Company Name: Erbe Elektromedizin GmbH

Primary DI Number: 04050147012806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316116623 *Terms of Use

Device Description: Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Surgical irrigation tubing set, single-use	A collection of sterile, flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline solution) from its source (e.g., gravity feed bag, feed pump) to a site of surgical intervention and/or endoscopy; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include a syringe or an integrated manual pump (e.g., a squeeze bulb). It does not include suction tubing and is not intended to aspirate the surgical/endoscopic site (i.e., not an irrigation/aspiration tubing set). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Surgical irrigation tubing set, single-use

A collection of sterile, flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline solution) from its source (e.g., gravity feed bag, feed pump) to a site of surgical intervention and/or endoscopy; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include a syringe or an integrated manual pump (e.g., a squeeze bulb). It does not include suction tubing and is not intended to aspirate the surgical/endoscopic site (i.e., not an irrigation/aspiration tubing set). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
OCX	endoscopic irrigation/suction system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103696	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

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Storage and Handling
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

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Size Type Text
Length: 3.500 Meter

Device Record Status

Public Device Record Key: 6dc7d6bf-f799-45d6-a019-6ad620f9dfaa
Public Version Date: August 06, 2018
Public Version Number: 4
DI Record Publish Date: December 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
04050147013193	7	04050147012806	In Commercial Distribution	Level: 1
04050147013209	5	04050147013193	In Commercial Distribution	Level: 2
04050147022065	10	04050147012806	In Commercial Distribution	Level: 1
04050147022072	3	04050147022065	In Commercial Distribution	Level: 2