AccessGUDID - DEVICE: Genius (10884521000353)

GUDID

Device Identifier (DI) Information

Brand Name: Genius
Version or Model: 8884110019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8884110019
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521000353
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 105
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Tympanic Probe Covers

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?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. 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 [?]
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
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5895bc9-b6c1-4f34-80cc-7d096586d33a
Public Version Date: April 11, 2024
Public Version Number: 8
DI Record Publish Date: April 20, 2017