SNOO Smart Sleeper

Primary DI
00817720020085
Brand
SNOO Smart Sleeper
Company
Happiest Baby, Inc.
Model
S1000
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.
Published
2024-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTGInfant Supine Sleep System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTGInfant Supine Sleep SystemGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817720020085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817720020085008177200200858177200200850817720020085

GMDN Terms#

Term, Definition table
TermDefinition
Rocking infant bed, electricAn 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).

Contacts#

Phone, Email table
PhoneEmail
855-424-6323customercare@happiestbaby.com

Regulatory Flags#

DUNS number
618462688
Device count
1
Premarket exempt
true
Lot or batch
true