FDA.reportPublic FDA data

Safety 1st

Primary DI
00884392004392
Brand
Safety 1st
Company
DOREL JUVENILE GROUP, INC.
Model
IH656
Device description
Baby's 1st Sneezes & Wheezes Kit
Published
2024-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical
KYXDispenser, Liquid Medication
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
KYXDispenser, Liquid MedicationGeneral Hospital1
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884392004399PackageGS12In Commercial Distribution
20884392004396PackageGS16In Commercial Distribution
00884392004392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088439200439910884392004399
2088439200439620884392004396
00884392004392008843920043928843920043920884392004392

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118841501
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884392020613Safety 1stTH1142026-05-28
00884392008420Safety 1stIH4262025-12-15
10884392008427Safety 1stIH4262025-12-15
00884392626020Safety 1stTH1042018-12-04
00884392949471Safety 1stIH5042023-11-15
20884392949475Safety 1stIH5042023-11-15
00884392950491Safety 1stIH5742023-06-15
10884392950498Safety 1stIH5752023-06-15
20884392950495Safety 1stIH5762023-06-15
30884392951079Safety 1stIH5942022-07-15
40884392951076Safety 1stIH5942022-07-15
00884392951078Safety 1stIH5942022-04-01
10884392951075Safety 1stIH5942022-04-01
20884392951072Safety 1stIH5952022-04-01
00884392625023Safety 1stIH4742018-11-29
00884392954451Safety 1stIH6012023-10-15
20884392954455Safety 1stIH6012023-10-15
10884392951822Safety 1stTH1112023-01-01
20884392951829Safety 1stTH1112023-01-01
00884392951825Safety 1stTH1112023-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22