SNOO Smart Sleeper

Basic Information

• Brand Name: SNOO Smart Sleeper
• Primary DI: 00817720020085
• Version / Model: S1000
• Company Name: Happiest Baby, Inc.
• Labeler DUNS: 618462688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-11
• Public Version: 1
• Public Version Date: 2024-07-19
• Public Version Status: New
• Public Device Record Key: 2b6d9795-a710-4b92-a1ca-3a51dcfada33

Device Description

The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
QTG	Infant Supine Sleep System	General Hospital	880.5690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37008	Rocking infant bed, electric	An electrically-powered bed designed to provide a motorized rocking movement to soothe an infant during sleep. The motorized mechanism is control-adjustable to provide variable degrees of movement and speed. Sometimes referred to as a rocking bassinet it consists of a soft flat platform with sides to prevent the infant from falling out. It may incorporate features to enable a safe sleeping position (e.g., supine sleeping bag).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817720020085	GS1

Customer Contacts

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