Identity
- Trade Name
- Little Journey FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- The device is an Ear and forehead thermometer, which is intended to measure human body temperature. FDA UDI
- Model / Reference
- DSO364 FDA UDI
- Description
- The device is an Ear and forehead thermometer, which is intended to measure human body temperature. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06926408700011 FDA UDI
- 510(k) Number
- K100488 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skinInfrared patient thermometer, ear
Little Journey by Shenzhen Dongdixin Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear.
- Famidoc — Famidoc Technology Company Limited · Class II
- Braun — KAZ USA, INC. · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
- Braun — KAZ USA, INC. · Class II
- Bytech — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class II
- Easy@Home Infrared Ear Thermometers — EASY HEALTHCARE CORPORATION · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
Cleared under the same submission
K100488 also covers:
- Exchange Select — Aafes
- SIGNATURE CARE — BETTER LIVING BRANDS LLC
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- HealthSmart — DMS HOLDINGS, INC.,
- Motorola — Exclusive Group, LLC
- Kroger — KROGER CO., THE
- Medline — MEDLINE INDUSTRIES, INC.
- Philips Avent ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- Philips ear thermometer — Shenzhen Dongdixin Technology Co., Ltd.
- UP & UP — TARGET CORPORATION
- UP&UP — TARGET CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (1)
- FDA UDI c6a8b8e6-cd61-4a13-8a61-2cd75b596c8e 34 fields · synced May 31, 2026