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ARC InstaTemp Non-Touch Infrared Thermometer

Primary DI
05391525574014
Brand
ARC InstaTemp Non-Touch Infrared Thermometer
Company
ARC DEVICES USA INC
Model
401
Device description
The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinical setting to measure temperature in infants and adult
Published
2017-03-31
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391525574014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391525574014053915255740145391525574014

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079758824
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
05391525574011ARC InstaTemp Non-Touch Infrared Thermometer4012017-03-31
00853524006016ARC InstaTemp Infrared Thermometer6012017-03-30
05391525570006ARC InstaTemp Non-Touch Thermometer0002017-03-27
05391525574004ARC InstaTemp MD Non-Touch Infrared Thermometer4002017-03-31
00853524006009ARC InstaTemp Infrared Thermometer6002017-03-27
00853524006023ARC InstaTemp Infrared Thermometer6022017-03-30
00853524006011ARC InstaTemp Infrared Thermometer6012017-03-30

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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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
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22