AccessGUDID - DEVICE: SONICAID (05051968029836)

GUDID

Device Identifier (DI) Information

Brand Name: SONICAID
Version or Model: ACC-OBS-009L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACC-OBS-009L
Company Name: HUNTLEIGH HEALTHCARE LIMITED

Primary DI Number: 05051968029836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217207083 *Terms of Use

Device Description: SONCD FM800 ENCOR EXT TOCO TDR-3M

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?
37258	Tocodynamometer probe	A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090285	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
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 680 and 1060 millibar
Storage Environment Atmospheric Pressure: between 680 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d16d8343-852c-4f6a-8630-3e1c07a7d988
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: September 12, 2016