AccessGUDID - DEVICE: Starboard Temperature Probes (00850933007054)

GUDID

Device Identifier (DI) Information

Brand Name: Starboard Temperature Probes
Version or Model: 40024-ES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40024-ES
Company Name: STARBOARD MEDICAL, INC.

Primary DI Number: 00850933007054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012983893 *Terms of Use

Device Description: Esophageal Stethoscope with 400 Series Temperature Sensor, 24 Fr.

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?
44120	Electronic oesophageal stethoscope, single-use	An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZT	Stethoscope, Esophageal, With Electrical Conductors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111050	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 1a528182-ba13-457d-9e3d-35d948f825b5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016