FDA UDI Not in Commercial Distribution 🇺🇸 United States

Dreambaby

DI: 06970392210988 · Model: DMT-4726 · JOYTECH HEALTHCARE CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Dreambaby
Primary DI
06970392210988
Version / Model
DMT-4726
Company Name
JOYTECH HEALTHCARE CO.,LTD
Labeler DUNS
544392778
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-15
Public Version
2
Public Version Date
2023-08-07
Public Version Status
Update
Public Device Record Key
e70ed534-6c85-4163-a2f7-d255e65c32b8
Distribution End Date
2023-08-05

Device Description

The digital thermometers are intended to measure the human body temperature in regular mode orally, rectally or under the arm, And the devices are reusable for clinical or home use on people ofall ages, including children under 8 years old with adult supervision.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FLL Thermometer, Electronic, Clinical

GMDN Terms

Code Name
14035 Intermittent electronic patient thermometer

Identifiers

Type ID
Package 16970392210985
Primary 06970392210988
Package 26970392210982