AccessGUDID - DEVICE: Mothership Wireless Fetal Transducer Base Station (00852189007376)

GUDID

Device Identifier (DI) Information

Brand Name: Mothership Wireless Fetal Transducer Base Station
Version or Model: F1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TENACORE HOLDINGS, INC.

Primary DI Number: 00852189007376
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138781799 *Terms of Use

Device Description: Mothership Wireless Fetal Transducer Base Station

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
38480	Cardiotocography telemetric monitoring system receiver	A mains electricity (AC-powered) component of a cardiotocography telemetric monitoring system designed to wirelessly receive, consolidate, and display foetal heart rate and uterine contraction signals from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a6c9e20-31b1-46d5-95a1-2d2598614912
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 16, 2017