FDA.report

ByFloProducts

Primary DI
00628693098144
Company
ByFlo LLC
Model
JZK-601
Device description
Infrared Forehead Thermometer
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
141150312
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00628693098205PackageGS150In Commercial Distribution
10628693098141PackageGS150In Commercial Distribution
00628693098144PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00628693098205PackageGS150Case00628693098144In Commercial Distribution
10628693098141PackageGS150Case00628693098144In Commercial Distribution
00628693098144PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FLLContinuous Measurement Thermometer2General Hospital880.2910NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1-669-220-8381support@byfloproducts.com

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