AccessGUDID - DEVICE: ThermiSense (00607411000256)

GUDID

Device Identifier (DI) Information

Brand Name: ThermiSense
Version or Model: 5730P-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5730P-0
Company Name: SALTER LABS

Primary DI Number: 00607411000256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleable plastic coated "T" shaped with 2 nasal and 1 oral elements for thermal airflow. 2.5 mm mono sub-mini plug to connection to the Alice® 3 PSG System.

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":	Yes
For Single-Use:	Yes
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?
35194	Respiratory apnoea monitoring system	An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, breathing frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151874	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 Temperature: between -40 and 60 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Pediatric

Device Record Status

Public Device Record Key: 6fdfec62-3205-47c1-8902-cfd6a5dd5bcd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016