AccessGUDID - DEVICE: PeriCALM® Curve™ (B087CURV02061)

GUDID

Device Identifier (DI) Information

Brand Name: PeriCALM® Curve™
Version or Model: 02.06.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PERIGEN SOLUTIONS LTD

Primary DI Number: B087CURV02061
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533337713 *Terms of Use

Device Description: PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.

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?
61956	Obstetrical monitoring/analysis software	A software program intended to facilitate clinical management of pregnancy and/or labour by providing functionality in one or more of the following areas: data acquisition, recording, analysis, and reporting. It typically processes maternal and/or foetal physiologic parameters [e.g., maternal heart rate (MHR) and foetal heart rate (FHR), maternal oxygen saturation (SpO2) and temperature, intrapartum foetal oxygen saturation (FSpO2), intrauterine/amniotic pressure], and is intended to be used in conjunction with specialized monitors in the maternity unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052715	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: a3d6e414-a64a-4bc6-b8d5-14b946ccc283
Public Version Date: November 25, 2019
Public Version Number: 5
DI Record Publish Date: May 30, 2016