AccessGUDID - DEVICE: iCE boom and Pendant (00684706002201)

GUDID

Device Identifier (DI) Information

Brand Name: iCE boom and Pendant
Version or Model: iCE - Spectra LP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP-L-2211-N-E
Company Name: Amico Clinical Solutions Corp

Primary DI Number: 00684706002201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243821688 *Terms of Use

Device Description: Spectra LP Electric Series - Dual Mount Dual Arm (1200mm-1200mm, 1000mm-1000mm)

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
35630	General utility supply system, ceiling-mounted	An assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	Table, Operating-Room, Ac-Powered

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eed26447-9939-4a81-8a92-d14cdece8a0f
Public Version Date: July 08, 2020
Public Version Number: 1
DI Record Publish Date: June 30, 2020