FDA.reportPublic FDA data

SIGNATURE CARE

Primary DI
10021130771292
Brand
SIGNATURE CARE
Company
BETTER LIVING BRANDS LLC
Model
2113077129
Catalog number
132-935-000
Device description
ALBERTSON DIGISCAN THERMOMETER
Published
2016-09-14
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100488000IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.2010-07-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10021130771292PackageGS124In Commercial Distribution
00021130771295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002113077129210021130771292
00021130771295000211307712950211307712950021130771295

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080349866
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
00321130762843Signature Care3211307628432020-08-10
00321130762850Signature Care3211307628502020-08-10
00321130788812Signature Care3211307888122020-07-31
00321130144724Signature Care3211301447242020-07-31
00321130078210Signature Care3211300782102020-07-31
00321130211419Signature Select3211302114192025-10-02
00321130211426Signature Select3211302114262025-10-02
00021130163830Signature Care Digital Pregnancy Test2021-04-16
00321130352945Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130163823Signature Care One Step Pregnancy Test2021-04-16
00321130195900Signature Care321130195900X004JE7MZP2022-12-12
00321130351115AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130351112AlbertsonsDigital Wide-Tip Pregnancy TestN/A2025-03-03
10321130352942Signature SelectOne Step Pregnancy TestN/A2025-02-27
00021130790005Signature Care Early Result Pregnancy Test2016-10-26
00321130195894Signature Care3211301958942022-12-12
10321130195891Signature Care3211301958942022-12-12
10321130195907Signature Care3211301959002022-12-12
00321130780595Safeway Facemask SAF384RSAF384R2016-09-24
00021130790050Signature Care Digital Pregnancy Test2016-10-26

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Primary DI, Brand, Company table
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
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