AccessGUDID - DEVICE: XT Anesthesia Workstation (AWS) (00860006285012)

GUDID

Device Identifier (DI) Information

Brand Name: XT Anesthesia Workstation (AWS)
Version or Model: XT-AWS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Omnicell, Inc.

Primary DI Number: 00860006285012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079417702 *Terms of Use

Device Description: The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system intended for securing and managing medications used by anesthesia providers and pharmacy staff.

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:	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?
34885	Anaesthesia cabinet	A furniture-like device, typically designed as a small cupboard on wheels, used for the secure storage of anaesthetic equipment and drugs. It typically includes an appropriate working surface for anaesthetics, instruments, vials, or other small devices. It is usually constructed to prevent the build-up of static electrical charges.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BRY	Cabinet, Table And Tray, Anesthesia

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: 9836b183-bc64-4e45-a6a6-e8fbb5e4cc76
Public Version Date: February 23, 2021
Public Version Number: 1
DI Record Publish Date: February 15, 2021