AccessGUDID - DEVICE: EnSite™ (05415067033581)

GUDID

Device Identifier (DI) Information

Brand Name: EnSite™
Version or Model: ENSITE-RAILMNT-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENSITE-RAILMNT-01
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067033581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Bedrail Mount

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?
61434	Portable active medical device mount	A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, diagnostic, programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202066	000
K221213	000
K223094	000
K231415	000
K242016	000

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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Temperature: between -25 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0854fdeb-9525-44be-9d72-2c893db73893
Public Version Date: February 06, 2025
Public Version Number: 7
DI Record Publish Date: January 06, 2021