Safety 1st

Basic Information

• Brand Name: Safety 1st
• Primary DI: 00884392954451
• Version / Model: IH601
• Company Name: DOREL JUVENILE GROUP, INC.
• Labeler DUNS: 118841501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-15
• Public Version: 1
• Public Version Date: 2023-10-23
• Public Version Status: New
• Public Device Record Key: 757ee44c-ebfa-43f3-924e-b82b25e3fe05

Device Description

ESSENTIAL SICK-DAY SCREENING KIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ERA	Otoscope	Ear, Nose, Throat	874.4770	1
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	1
FMA	Depressor, Tongue, Non-Surgical	General Hospital	880.6230	1
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63659	Tongue depressor, examination, reusable	A 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.	No	Active
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active
41826	Nasal aspirator, manual	A portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.	No	Active
14035	Intermittent electronic patient thermometer	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884392954451	GS1