AccessGUDID - DEVICE: NA (04055207054116)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 4170502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4170502
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207054116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: INSUFFLATION TUBE SET L 3M high-flow with heating coil and integrated hygiene filter, PVC, PACK=10 PCS, for insufflators 2235021, 2235031, 2235621 and 2235631, sterile, for single use

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

[?]

Product Code	Product Code Name
HIF	INSUFFLATOR, LAPAROSCOPIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000180	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Meter

Device Record Status

Public Device Record Key: deda716c-ca75-4fcd-b442-b4fad7e1fb54
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 28, 2017