Dr. Brown's

Basic Information

• Brand Name: Dr. Brown's
• Primary DI: B740TE0090
• Version / Model: TE009
• Company Name: HANDI-CRAFT COMPANY
• Labeler DUNS: 055872634
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-15
• Public Version: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 50cdd924-ab24-49f7-aea6-d66e7ef6c327
• Distribution End Date: 2020-09-16

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	B740TE0090	HIBCC

Customer Contacts

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