AccessGUDID - DEVICE: Mini Telemetry System (00840682117166)

GUDID

Device Identifier (DI) Information

Brand Name: Mini Telemetry System
Version or Model: 2051440-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WIPRO GE HEALTHCARE PRIVATE LIMITED

Primary DI Number: 00840682117166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 650140403 *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):	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?
38479	Cardiotocography telemetric monitoring system	An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a cardiotocograph/monitor. It typically consists of wireless patient worn transducers/electrodes (e.g., leads and electrodes or Doppler ultrasound transducer plus pressure transducer) with appropriate transmitting capability and a receiver unit; the cardiotocograph/monitor is not included. The system is typically used for ambulatory patients who require continuous monitoring before delivery.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	SYSTEM, MONITORING, PERINATAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110556	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 5 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a18e6b5-4fae-49ab-983d-f651a19f8dd3
Public Version Date: December 10, 2019
Public Version Number: 4
DI Record Publish Date: June 24, 2016