RELION

Primary DI
10681131060278
Brand
RELION
Company
WAL-MART STORES, INC.
Model
144-639-000
Catalog number
144-639-000
Device description
RELION BASAL DIGITAL THERM
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10681131060278PackageGS112In Commercial Distribution
00681131060271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068113106027810681131060278
00681131060271006811310602716811310602710681131060271

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
051957769
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
00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02
00681131106108Equate5998092362026-02-25
00681131106092Equate5997602702026-02-25
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00194346404155EquateEM472026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28
00194346699421EquateFBL7100072026-04-17
00194346219230ReliOn™ Premier Classic Meter784001N/A2025-02-11

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
10767056156392MABISD-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