AccessGUDID - DEVICE: Somnostar (10846446033298)

GUDID

Device Identifier (DI) Information

Brand Name: Somnostar
Version or Model: 29675-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 29675-001
Company Name: Carefusion Corporation

Primary DI Number: 10846446033298
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830432451 *Terms of Use

Device Description: SOMNOSTAR 11 UPGRADE

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38452	Desktop computer	A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLV	Standard Polysomnograph With Electroencephalograph

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: affda20d-dc29-4053-bd40-91b1a73ee5a6
Public Version Date: June 06, 2024
Public Version Number: 7
DI Record Publish Date: September 13, 2016