FDA.reportPublic FDA data

ONE-CARE Non-Contact Infrared Thermometer

Primary DI
00810008218013
Brand
ONE-CARE Non-Contact Infrared Thermometer
Company
MediVena, LLC
Model
4021 ONE-CARE Non-Contact Infrared Thermometer HTD
Catalog number
4021
Device description
The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrared thermometer with two modes for multi-measurement: body mode for measuring forehead temperature and surface mode for measuring the temperature of objects such as rooms, milk, food, water, etc.
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203332000Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CHetaida Technology Co., Ltd.2021-02-25FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008218013PackageGS140In Commercial Distribution
00810008218006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008218013008100082180138100082180130810008218013
00810008218006008100082180068100082180060810008218006

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height37Millimeter
Length140Millimeter
Width44Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4045142586info@medivena.com

Regulatory Flags#

DUNS number
080740980
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008211519ONE-CARE Pen Needles,3018-ONE-CARE Pen Needles, 31G x 6mm, Blue, 100ct,30182025-03-12
00810008217221GLUCO-CARE PLUS Pen Needles3026-GLUCO-CARE PLUS Pen Needles, 31G x 5mm, Purpl30262025-11-11
00810008210147ONE-CARE Safety Lancets1106 ONE-CARE Safety Lancets 21G x 2.4mm, ExtraFlo11062025-10-23
00810008211502ONE-CARE Pen Needles3017-ONE-CARE Pen Needles, 31G x 5mm, Purple, 100c30172025-10-20
00810008214015ONE-CARE Pen Needles3011-ONE-CARE Pen Needles 33G x 4mm, Pink, 100/bx,30112025-10-20
00810008214275ONE-CARE Pen Needles3016-ONE-CARE Pen Needles 31G x 4mm, Sky Blue, 10030162025-10-20
00810008215654ONE-CARE Insulin Syringes "2274 ONE-CARE Insulin Syringes 1ml/cc, 31g x 5/1622742025-10-15
00810008215685ONE-CARE Insulin Syringes "2275 ONE-CARE Insulin Syringes 1ml/cc, 30G x 5/1622752025-10-15
00810008215715ONE-CARE Insulin Syringes "2276 ONE-CARE Insulin Syringes 1ml/cc, 30G x 1/2"22762025-10-15
00810008215746ONE-CARE Insulin Syringes "2278 ONE-CARE Insulin Syringes 1ml/cc, 27G x 1/2"22782025-10-15
00810008216507ONE-CARE Insulin Syringes "2277 ONE-CARE Insulin Syringes 1ml/cc, 29G x 1/2"22772025-10-15
00810008217429ONE-CARE Insulin Syringes 2288 ONE-CARE Insulin Syringes 0.3ml 31Gx6mm, Blis22882025-10-15
00810008218259ONE-CARE Insulin Syringes 2291 ONE-CARE Insulin Syringes 0.3ml 31Gx8mm, Bli22912025-10-15
00810008218419ONE-CARE Insulin Syringes 2290 ONE-CARE Insulin Syringes 1ml 31Gx6mm, Blist22902025-10-15
00810008218440ONE-CARE Insulin Syringes 2292 ONE-CARE Insulin Syringes 0.5ml 31Gx8mm, Bli22922025-10-15
00810008218471ONE-CARE Insulin Syringes 2293 ONE-CARE Insulin Syringes 1ml 31Gx8mm, Blist22932025-10-15
00810008218501ONE-CARE Insulin Syringes 2294 ONE-CARE Insulin Syringes 0.3ml 30Gx12.7mm, B22942025-10-15
00810008218532ONE-CARE Insulin Syringes 2295 ONE-CARE Insulin Syringes 0.5ml 30Gx12.7mm, 22952025-10-15
00810008218563ONE-CARE Insulin Syringes 2296 ONE-CARE Insulin Syringes 1ml 30Gx12.7mm, Bl22962025-10-15
00810008214435ONE-CARE Insulin Syringes "2271 ONE-CARE Insulin Syringes 0.3ml/cc, 31g x 5/22712025-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22