FDA.report

MABIS

Primary DI
00767056157200
Brand
MABIS
Company
D-M-S HOLDINGS, INC.
Model
15-720-000
Catalog number
15-720-000
Device description
JUMBO DISPLAY DIGITAL THERMOMETER W/BEEPER & MEMORY FAHRENHEIT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00107656157208PackageGS118In Commercial Distribution
30767056157201PackageGS14In Commercial Distribution
00767056157200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00107656157208001076561572081076561572080107656157208
3076705615720130767056157201
00767056157200007670561572007670561572000767056157200

GMDN Terms

TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062028220
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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