AccessGUDID - DEVICE: Tarry Probes (00854758006087)

GUDID

Device Identifier (DI) Information

Brand Name: Tarry Probes
Version or Model: T 97700
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: T 97700
Company Name: TARRY MEDICAL PRODUCTS, INC.

Primary DI Number: 00854758006087
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 107260002 *Terms of Use

Device Description: T 97700 Reusable Use Skin Temperature Probe

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?
37340	General-purpose patient temperature probe, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMT	Warmer, Infant Radiant
FMZ	Incubator, Neonatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071977	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: f6bf4464-704d-44a8-93bd-d2f28bbb8d7a
Public Version Date: September 25, 2018
Public Version Number: 4
DI Record Publish Date: September 20, 2016