AccessGUDID - DEVICE: Geratherm Thermometer Sheaths (00614801100304)

GUDID

Device Identifier (DI) Information

Brand Name: Geratherm Thermometer Sheaths
Version or Model: Sheaths fits non mercury glass thermometers
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10030
Company Name: R.G. ENTERPRISES (U.S.A.), INC.

Primary DI Number: 00614801100304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928998905 *Terms of Use

Device Description: Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free oral or rectal thermometers. They are a single use disposable item.

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):	No
Over the Counter (OTC):	Yes
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?
42391	Capillary thermometer cover	A device intended to be used as a physical barrier for an alcohol or mercury capillary thermometer to prevent cross-contamination between patients and/or environmental exposure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental Barriers And Sleeves

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d9028e9-9b81-43c4-a25c-b74db6337962
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016