AccessGUDID - DEVICE: Optitherm (04048551068663)

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Device Identifier (DI) Information

Brand Name: Optitherm
Version or Model: 20432030
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551068663
Issuing Agency: GS1
Device Count: 1

Device Description: Optitherm® Heating Element

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
Insufflation gas conditioning system	An assembly of devices used with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It typically consists of a mains electricity (AC-powered) control unit, a humidification chamber through which cold/dry gas passes for conditioning, and a tubing set for connection to the gas source and delivery of the conditioned gas to the operative site. Conditioning of the gas helps alleviate problems associated with gas insufflation, i.e., desiccation of internal tissue and body temperature loss.

GMDN Preferred Term Name

GMDN Definition

Insufflation gas conditioning system

An assembly of devices used with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It typically consists of a mains electricity (AC-powered) control unit, a humidification chamber through which cold/dry gas passes for conditioning, and a tubing set for connection to the gas source and delivery of the conditioned gas to the operative site. Conditioning of the gas helps alleviate problems associated with gas insufflation, i.e., desiccation of internal tissue and body temperature loss.

FDA Product Code

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Product Code	Product Code Name
HIF	INSUFFLATOR, LAPAROSCOPIC

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
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: Optitherm (04048551068663)