AccessGUDID - DEVICE: Engage Medical Device Alert Notification System (EMDAN) (00860002177779)

GUDID

Device Identifier (DI) Information

Brand Name: Engage Medical Device Alert Notification System (EMDAN)
Version or Model: 910-01947
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 910-01947
Company Name: STRYKER CORPORATION

Primary DI Number: 00860002177779
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078470558 *Terms of Use

Device Description: No description.

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?
40573	Alarm application software	An individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines can be upgraded to correct programming errors or to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSX	System, network and communication, physiological monitors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130339	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5046ff1-4945-4b6a-856e-adfd44beb740
Public Version Date: August 26, 2022
Public Version Number: 1
DI Record Publish Date: August 18, 2022