FDA.report

Genius

Primary DI
50192253008331
Brand
Genius
Company
Cardinal Health 200, LLC
Model
303030
Catalog number
303030-
Device description
Genius Probe Covers
Published
2020-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLLThermometer, electronic, clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253008331PackageGS122In Commercial Distribution
20192253008330PrimaryGS10
10192253008333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225300833150192253008331
2019225300833020192253008330
1019225300833310192253008333

GMDN Terms

TermDefinition
Electronic thermometer probe coverA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
96
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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