AccessGUDID - DEVICE: Gimmi (04049047656357)

GUDID

Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: Y.0598.22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Y.0598.22
Company Name: Gimmi GmbH

Primary DI Number: 04049047656357
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316152610 *Terms of Use

Device Description: ADOS LUER LOCK MALE 2.85 MM INNER

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 instrument cleaning adaptor, reusable	A device intended to connect the lumen of an appropriate surgical instrument (e.g., an endoscope), or other cleaning tool, to the tubing of a device washer/decontaminator, or a tap, to facilitate an improved intraluminal flush and/or other cleaning of a surgical instrument. It is typically used for pre-cleaning (i.e., removal of gross blood and other organic debris) prior to disinfection or sterilization. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical instrument cleaning adaptor, reusable

A device intended to connect the lumen of an appropriate surgical instrument (e.g., an endoscope), or other cleaning tool, to the tubing of a device washer/decontaminator, or a tap, to facilitate an improved intraluminal flush and/or other cleaning of a surgical instrument. It is typically used for pre-cleaning (i.e., removal of gross blood and other organic debris) prior to disinfection or sterilization. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5cf52b98-f8db-49bb-a3f8-0e05d820978b
Public Version Date: February 21, 2019
Public Version Number: 4
DI Record Publish Date: May 05, 2017