Couplet Care Bassinet

Basic Information

• Brand Name: Couplet Care Bassinet
• Primary DI: 00199284746916
• Version / Model: CCB0100
• Company Name: Couplet Care, Inc.
• Labeler DUNS: 081464366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-21
• Public Version: 1
• Public Version Date: 2026-01-29
• Public Version Status: New
• Public Device Record Key: b2358173-1a67-49b3-8e55-04c6b73bd7cd

Device Description

The Couplet Care Bassinet is for use in hospitals and birthing centers. It creates a bridge for mother-infant connection. This access is important for infant feeding, safe sleep, and maternal healing.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NZG	Bassinet, Hospital	General Hospital	880.5145	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38140	Neonatal bed	A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00199284746916	GS1