AccessGUDID - DEVICE: PeriWatch Vigilance Tracings (00862095000491)

GUDID

Device Identifier (DI) Information

Brand Name: PeriWatch Vigilance Tracings
Version or Model: 2019 Rev 1.02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PERIGEN INC.

Primary DI Number: 00862095000491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080813890 *Terms of Use

Device Description: PeriWatch Vigilance Tracings is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store, and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. It organizes clinical data that would normally be provided on paper records or other clinical systems and devices. The system also serves a a decision support tool and electronic medical record.

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?
44104	Obstetrics information system application software	An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. It is typically supplied for installation into a dedicated obstetrics information system or existing mainframe or decentralized computers/networks and is used in a labour ward/maternity unit and allows the electronic entry of a patient’s details of labour for viewing at different locations.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080226	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: 2b87e1ee-ca9e-406b-83f9-bc033b4d1299
Public Version Date: November 07, 2019
Public Version Number: 1
DI Record Publish Date: October 30, 2019