MABIS

Primary DI
10767056156392
Brand
MABIS
Company
D-M-S HOLDINGS, INC.
Model
15-639-000
Catalog number
15-639-000
Device description
BASAL DIGITAL THERMOMETER W/BEEPER & MEMORY WATERPROOF
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

Product Codes#

Code, Name table
CodeName
OZKThermometer, Exhaled Breath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZKThermometer, Exhaled BreathGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962520000DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823AMesure Technology1996-09-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10767056156392PackageGS112In Commercial Distribution
30767056156396PackageGS16In Commercial Distribution
00767056156395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076705615639210767056156392
3076705615639630767056156396
00767056156395007670561563957670561563950767056156395

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23
00767056600119MABIS05-260-01105-260-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063675130LPOWHangzhou Universal Electronic Co.,Ltd.OZK2024-05-28
00767056156395MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00767056156814MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156811MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00036800396920TOPCARETopco Associates, LLCOZK2016-09-12
10036800396927TOPCARETopco Associates, LLCOZK2016-09-12
00681131060271RELIONWAL-MART STORES, INC.OZK2016-08-17
10681131060278RELIONWAL-MART STORES, INC.OZK2016-08-17