AccessGUDID - DEVICE: Truer Medical, Inc. (00859290006113)

GUDID

Device Identifier (DI) Information

Brand Name: Truer Medical, Inc.
Version or Model: GP 9400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GP 9400
Company Name: TRUER MEDICAL, INC.

Primary DI Number: 00859290006113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003530786 *Terms of Use

Device Description: Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort.

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:	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?
35254	General-purpose patient temperature probe, single-use	A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101244	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9e99d6b-309e-42c4-82a7-d7cc4a553fa1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 06, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
40859290006111	6	20859290006117	In Commercial Distribution	Carton
30859290006114	5	20859290006117	In Commercial Distribution	Carton
20859290006117	2	10859290006110	In Commercial Distribution	Carton
10859290006110	50	00859290006113	In Commercial Distribution	Carton