AccessGUDID - DEVICE: CI-55 Anesthesia Holster (M996CI550)

GUDID

Device Identifier (DI) Information

Brand Name: CI-55 Anesthesia Holster
Version or Model: CI-55
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CI-55
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996CI550
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The CI-55 Anesthesia Holster is a device used to store and handle soiled laryngoscope blades and suction tips to prevent cross contamination and pathogen transmission in the anesthesia work area during intubation of a patient . The CI-55 Anesthesia Holster allows for safe storage and handling of contaminated items such as laryngoscope blades and suction tips until they can be discarded or sent for re-processing. This device is Single Patient Use. Packaged as non-sterile.

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

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41893	Medical device service rail clamp	A clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 349cab46-a103-4568-a1ad-2cb8b8fe3296
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2017