Dr. Brown's

Basic Information

• Brand Name: Dr. Brown's
• Primary DI: B740TE0240
• Version / Model: TE024
• Company Name: HANDI-CRAFT COMPANY
• Labeler DUNS: 055872634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 3
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 50a5c82b-0c78-43e2-8493-5e3483fe497d

Device Description

AquaCool Water Filled Teether

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: Yes
• 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
KKO	Ring, Teething, Fluid-Filled	Dental	872.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10243	Infant care kit	A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B740TE0240	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]