FDA.reportPublic FDA data

Safety 1st

Primary DI
00884392954451
Brand
Safety 1st
Company
DOREL JUVENILE GROUP, INC.
Model
IH601
Device description
ESSENTIAL SICK-DAY SCREENING KIT
Published
2023-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ERAOtoscope
FLLThermometer, Electronic, Clinical
FMADepressor, Tongue, Non-Surgical
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
FLLContinuous Measurement ThermometerGeneral Hospital2
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884392954451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884392954451008843929544518843929544510884392954451

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, reusableA hand-held device intended to be used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make it less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a reusable device after appropriate cleaning.

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
00884392004392Safety 1stIH6562024-12-15
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
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
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
10080196456765MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-14
10080196031764MEDLINEMEDLINE INDUSTRIES, INC.KYZ2026-07-13
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
00840456200278JMUJMU DENTAL, INCFMA2026-07-10
00840456213605JMUJMU DENTAL, INCFMA2026-07-10
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
00840456213575JMUJMU DENTAL, INCFMA2026-07-08
00840456213582JMUJMU DENTAL, INCFMA2026-07-08
00840456213599JMUJMU DENTAL, INCFMA2026-07-08
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
05060212050687Bruenings Tongue Depressor, 190mmDTR MEDICAL LIMITEDFMA2026-06-10
10198956501645CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-06-08
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03