FDA.report

NA

Primary DI
00697077001094
Brand
NA
Company
Amico Diagnostic Incorporated
Model
DS-UA1-CHFH-DLI
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00697077001094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077001094006970770010946970770010940697077001094

GMDN Terms

TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-462-6426info@amico-accessories.com

Regulatory Flags

DUNS number
203163290
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

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00697077003074Amico Diagnostic CuffCR2-LF13W-2BV2025-04-04
00697077002633Amico Diagnostic CuffCR2-LF07O-2BVSM2020-11-16
00697077003043DS-UDN-CLFL-DAIDS-UDN-CLFL-DAI2024-07-11
00697077003050Amico Diagnostic, Inc.DS-ULG-CLFL-DAO2024-09-18
00697077003036NAAM-GL-LF21182024-06-24
00697077003029NADS-UV1-CLFL-DXX2024-05-02
00697077002237NADS-UHM-CHFH-DAX2023-07-27
00697077002985NACR2-LF09G-2SF2023-07-27
00697077002992NACR2-LF07O-2SF2023-07-27
00697077003005NACR2-LF10B-2SF2023-07-27
00697077003012NACR2-LF12M-2SF2023-07-27
00697077002978NACR2-LFMLT-2BVSF2023-07-05
00697077002961NACR2-LF10B-2BVSM2023-04-18
00697077002923NADS-ELG-CLFL-DAX2022-02-02
00697077002930NADS-EDM-CLFL-XXX2022-02-02
00697077002916NADS-UF2-CLFL-DAI2021-09-03
00697077002909NADS-UF2-CHFH-DAX2021-06-22
00697077002893NATP-V-OP92021-04-05

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