AccessGUDID - DEVICE: NA (04055207048566)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 4170503
Catalog Number: 4170503
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207048566
Issuing Agency: GS1
Device Count: 10

Device Description: SMOKE ASPIRATION TUBE SET L 2.7M PVC, PACK=10 PCS, for insufflators 45 2235011, 2235031, 2235611 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

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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 fluid/smoke waste management system suction unit	A mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

GMDN Preferred Term Name

GMDN Definition

Surgical fluid/smoke waste management system suction unit

A mobile, mains electricity (AC-powered) device assembly designed to collect surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a suction pump, tubing, collection containers, a vacuum gauge, a vacuum control knob, an overflow trap, and a special filter for smoke evacuation. It uses negative pressure (suction) at the site of intervention to collect fluid in its collection containers and filter captured smoke with its filters. It is attached to a dedicated disposal unit for automatic container emptying and cleaning to prepare for the next use.

FDA Product Code

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Product Code	Product Code Name
NKC	Tubing/tubing with filter, insufflation, laparoscopic

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 2.7 Meter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: June 28, 2017
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: NA (04055207048566)